Risk Management and the Impact of EN ISO 14971:2012 Annex Z
|
|
- Jonathan Cox
- 7 years ago
- Views:
Transcription
1 Risk Management and the Impact of EN ISO 14971:2012 Annex Z BSI 2014 Medical Device Mini-Roadshow Ibim Tariah Ph.D Technical Director, Healthcare Solutions Copyright 2014 BSI. All rights reserved. 1
2 Risk Management - Impact of Annex Z Overview of ISO 14971:2007 EN ISO 14971:2012 Harmonized Standard Differences from ISO Standard and 2009 version Deviations Presumption of Conformity BSI Audits FAQs Regarding EN ISO 14971:2012* * Included in presentation materials but not discussed Copyright 2014 BSI. All rights reserved. 2
3 ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices Copyright 2014 BSI. All rights reserved. 3
4 Definitions Risk = Combination of the probability of occurrence of harm and the severity of that harm Harm = Physical injury or damage to the health of people, or damage to property, or the environment Severity Low High No harm Death / Serious Injury Occurrence Improbable Frequent < X% Y Z% (Sometimes factor of occurrence of hazard x % of harm / hazard) Copyright 2014 BSI. All rights reserved. 4
5 ISO Main body (Clauses 1-3) 1 Scope 2 Terms and definitions 3 General requirements for risk management 3.1 Risk management process 3.2 Management responsibilities 3.3 Qualification of personnel 3.4 Risk management plan 3.5 Risk management file Copyright 2014 BSI. All rights reserved. 5
6 ISO Main body (Clauses 4-9) Clause 4: Risk analysis Clause 9: Post-production information Clause 5: Risk evaluation Clause 8: Risk management report Clause 6: Risk control Clause 7: Residual risk evaluation Copyright 2014 BSI. All rights reserved. 6
7 ISO Overview of Annexes Annex A Annex B Annex C Annex D Annex E (informative) Rationale for requirements (informative) Overview of the risk management process for medical devices (informative) Questions that can be used to identify medical device characteristics that could impact on safety (informative) Risk concepts applied to medical devices (informative) Examples of hazards, foreseeable sequences of events and hazardous situations risk control benefit estimation qualitative analysis ALARP probability Copyright 2014 BSI. All rights reserved. 7
8 ISO Overview of Annexes Annex F Annex G Annex H Annex I Annex J (informative) Risk management plan (informative) Information on risk management techniques (informative) Guidance on risk management for in vitro diagnostic (IVD) medical devices (informative) Guidance on risk analysis process for biological hazards (informative) Information for safety and information about residual risk PHA FTA HACCP FMEA HAZOP Copyright 2014 BSI. All rights reserved. 8
9 Risk Management EU Requirements MDD AIMDD IVDD Copyright 2014 BSI. All rights reserved. 9
10 Medical Devices EU Risk Requirements Risks > Benefits Benefits > Risks Risks R B R B Benefits Copyright 2014 BSI. All rights reserved. 10
11 The Directives Where is Risk? Risk MDD 93/42/EEC ERs: , 7.4, 7.5, , , , , 12.5, 12.6, , 13.6 AIMDD 90/385/EEC ERs: IVDD 98/79/EC ERs: A 1 2 B , 2.2, 2.5, , 3.3, , 6.3, , 8.7 Total Copyright 2014 BSI. All rights reserved. 11
12 EN ISO 14971:2012 EU harmonized standard for Risk Management Allows the presumption of conformity to MDD, AIMD, and IVD Published July 2012 & harmonized as of 30 August Copyright 2014 BSI. All rights reserved. 12
13 What is the difference? ISO 14971:2007 The current International Standard EN ISO 14971:2009 The previous version of the European Harmonized Standard Obsolete as of 30 August 2012 EN ISO 14971:2012 The current European Harmonized Standard Changes within Foreword & Annex Zs only No change to requirements (Normative Text) i.e. clauses or requirements of the standard are exactly the same Copyright 2014 BSI. All rights reserved. 13
14 Why was EN ISO 14971:2012 created? A solution to formal objections raised by Swedish Competent Authority & European Commission on the harmonized status of a number of European Standards Revision of Annex Z s was made to provide greater clarity on applicability & alignment of ISO clauses with requirements of AIMDD, MDD & IVDD Copyright 2014 BSI. All rights reserved. 14
15 EN ISO 14971:2012 Z Annexes Example Annex ZA (MDD) Explains to which requirements, under which conditions and to what extent presumption of conformity can be claimed. Copyright 2014 BSI. All rights reserved. 15
16 EN ISO 14971:2009 Z Annexes (Now Obsolete) Compliance with all the requirement clauses in this standard will ensure that general aspects of medical devices related to patient risk and safety have been addressed. For particular medical devices or for particular safety aspects, additional specific requirements may need to be complied with in order to meet the essential requirements. Copyright 2014 BSI. All rights reserved. 16
17 EN ISO 14971:2012 Content Deviations Copyright 2014 BSI. All rights reserved. 17
18 EN ISO 14971:2012 Content Deviations Essential Requirements (ERs) Impacted Deviation MDD AIMDD IVDD 1 Treatment of negligible risks 1, 2, 6, 7.1 1, 5, 9 A.1, A.2, B Discretionary power of mfr as to acceptability of risks 3 Risk reduction as far as possible vs. as low as reasonably practicable 4 Discretion as to whether a riskbenefit analysis needs to take place 5 Discretion as to the risk control options / measures 6 Deviation as to the first risk control option 7 Information of the users influencing the residual risk 1, 2, 6, 7.1 1, 5, 9 A.1, A.2, B.1.1 1, 2, 6, 7.1 1, 5, 6, 9 A.1, A.2, B.1.1 1, 6, & 9 A.1 & B & A.2 & B & A.2 & B & A.2 & B.1.1 Copyright 2014 BSI. All rights reserved. 18
19 Deviation No. 1 MDD (AIMDD) IVDD...all risks, regardless of their dimension, need to be reduced as much as possible (and need to be balanced, together with all other risks, against the benefit of the device). ISO D the manufacturer may discard negligible risks. Copyright 2014 BSI. All rights reserved. 19
20 Were all risks considered for mitigation? Failure Mode Cause of Failure Local Effect System Effect Initial Rating Risk Control Measure(s) Risk Level RPN PRO SEV Hip Stem Surgeon implants a stem that is wrongly sized No tool available to determine needed size Unstable Implant Revision X-ray templates provided for each implant size; implants marked with It is not sufficient just to determine that the risks are acceptable. It is also necessary to determine whether they have been reduced as far as possible. This can be stated line-by-line or categorically as a whole. size; clinical history of safety / performance Acceptable Broadly & Acceptable reduced as far as possible Copyright 2014 BSI. All rights reserved. 20
21 Deviation No. 2 MDD (AIMDD) IVDD...all risks have to be reduced as far as possible (and that all risks combined, regardless of any "acceptability" assessment, need to be balanced, together with all other risks, against the benefit of the device). ISO , 6.4, 6.5 & 7...manufacturers have the freedom to decide upon the threshold for risk acceptability. D.6.1 only nonacceptable risks have to be integrated into the overall riskbenefit analysis. Copyright 2014 BSI. All rights reserved. 21
22 Are all risks reduced as far as possible? Unacceptable Extent of damage Management Review Required - ALARP 10 9 Broadly Acceptable 8 7 Some risks cannot be categorically ignored if risk can be reduced further. All risks must be reduced as far as possible Probability of occurrence Copyright 2014 BSI. All rights reserved. 22
23 Deviation No. 3 MDD AIMD IVD...risks to be reduced "as far as possible" without there being room for economic considerations. ISO & D.8 contains the concept of reducing risks "as low as reasonably practicable. The ALARP concept contains an element of economic consideration. Copyright 2014 BSI. All rights reserved. 23
24 Are all risks reduced as far as possible? Extent of damage There must be another step ALARP concept should not allow economic factors to hinder mitigation, risks must be reduced as far as possible within stateof-the-art Probability of occurrence Copyright 2014 BSI. All rights reserved. 24
25 Were risks reduced as far as possible? Failure Mode Cause of Failure Local Effect System Effect Initial Rating Risk Control Measure(s) Risk Level RPN PRO SEV Hip Stem Surgeon implants a stem that is wrongly sized No tool available to determine needed size Unstable Implant Revision X-ray templates provided for every-other implant size; implants marked with size It is not reasonable in this example not to provide templates for each size. The economic impact of this should not be considered if this can reduce the risk. To make this determination, the state-of-the-art and available technology should be considered. ALARP Copyright 2014 BSI. All rights reserved. 25
26 Deviation No. 4 MDD AIMDD (IVDD)...an overall risk-benefit analysis must take place in any case, regardless of the criteria established in the mgmt plan of the mfr... (and requires undesirable side effects to "constitute an acceptable risk when weighed against the performance intended ). ISO an overall riskbenefit analysis does not need to take place if the overall residual risk is judged acceptable when using the criteria established in the risk mgmt plan. D.6.1 "A risk/benefit analysis is not required by this Int l Std for every risk. Copyright 2014 BSI. All rights reserved. 26
27 The Directives Where is Benefit? Benefit MDD 93/42/EEC ERs: AIMDD 90/385/EEC ERs: 10 IVDD 98/79/EC ERs: A 1 Total Risk MEDDEV Guidelines on Clinical Evaluation Report also discusses Risk / Benefit Analysis Copyright 2014 BSI. All rights reserved. 27
28 Risk / benefit analysis done for all risks? Frequent 2 Conduct Risk v Benefit Probable 6 4 Consider Risk v Benefit Occasional 3 Acceptable Remote 3 Improbable 2 There must be a risk benefit analysis for all risks and an overall risk benefit analysis not just unacceptable risks Copyright 2014 BSI. All rights reserved. 28
29 Documentation of Risk / Benefit Analysis Risk Management File o Combination of risk assessment / risk management report Clinical Evaluation Report (Frequently addressed here) Copyright 2014 BSI. All rights reserved. 29
30 Deviation No. 5 MDD IVDD... to select the most appropriate solutions...by applying cumulatively what has been called "control options or "control mechanisms" in the standard. ISO obliges the mfr to "use one or more of the following risk control options in the priority order listed. 6.4 indicates that further risk control measures do not need to be taken if, after applying one of the options, the risk is judged acceptable according to the criteria of the risk mgmt plan. Copyright 2014 BSI. All rights reserved. 30
31 All appropriate controls utilized? Failure Mode Cause of Failure Local Effect System Effect Initial Rating Risk Control Measure(s) Risk Level RPN PRO SEV Intracranial Pressure Monitor High pressure undetected Monitor does not indicate high pressure situation Brain damage No control measures mentioned about alarms / warnings for high pressure situation. The current mitigation is not considered to be sufficient as preventive measures could mitigate the risk. Death Monitor provides continuous digital display of ICP; operates on AC & for up to 3 hrs on battery ALARP Copyright 2014 BSI. All rights reserved. 31
32 Deviation No. 6 MDD (IVDD)..."eliminate or reduce risks as far as possible (inherently safe design and construction)". ISO obliges the manufacturer to "use one or more of the following risk control options in the priority order listed: (a) inherent safety by design... without determining what is meant by this term. Copyright 2014 BSI. All rights reserved. 32
33 Were risks designed out if possible? Failure Mode Cause of Failure Local Effect System Effect SEV Initial Rating PRO RPN Risk Control Measure(s) Risk Level Mesh Mesh frays and suture pulls out Design of mesh / cutting edge Failed repair Risks must be designed out if possible. All risk control options must be applied until risks have been reduced as much as possible and any additional control option(s) do not improve the safety Revision Warp IFU knit Acceptable mesh instructs & reduced design not to cut as far as prevents mesh and possible fraying not to after place cut; multiple sutures sizes closer available; than 5 suture mm to pullout edge testing Copyright 2014 BSI. All rights reserved. 33
34 Deviation No. 7 MDD (IVDD)...users shall be informed about the residual risks. This indicates that...the information given to the users does not reduce the (residual) risk any further. ISO & 6.4 residual risk is defined as the risk remaining after application of risk control measures. 6.2 regards "information for safety" to be a control option. Copyright 2014 BSI. All rights reserved. 34
35 Residual risks incorrectly reduced? Device Failure Mode Effect Initial Rating Risk Control Updated Rating RPN PRO SEV RPN PRO SEV Implant Emboli Death IFU warning A warning does not reduce the probability of occurrence of an emboli. Copyright 2014 BSI. All rights reserved. 35
36 Residual risks incorrectly reduced? Device Failure Mode Effect Initial Rating Risk Control Updated Rating RPN PRO SEV RPN PRO SEV Mesh with Barrier Membrane Device implanted upsidedown Adhesions 4 3 Instructions on how to use the device properly may mitigate the risk 12 IFU contains pictures / instructions on how to correctly orient device with marked side down Copyright 2014 BSI. All rights reserved. 36
37 BSI Audits Copyright 2014 BSI. All rights reserved. 37
38 Conformity Assessment Quality System n=70 Americas n=50 EMEA n=40 Asia- Pacific External Resource n=as needed Microbiologist n=20 Technical Specialist n=80 Copyright 2014 BSI. All rights reserved. 38
39 BSI Audit Key Questions Are you aware of EN ISO 14971:2012? How are you ensuring you meet the directive requirements? Have you reviewed your existing Risk Management files, if needed? Is there a plan in place to do so? Copyright 2014 BSI. All rights reserved. 39
40 BSI Audit Key Questions Have all risks been reduced as far as possible? Has a risk benefit analysis been conducted for all risks? Have all risks been designed out if possible? Have risks been incorrectly reduced by warnings placed on IFUs or provided in training? Copyright 2014 BSI. All rights reserved. 40
41 Questions Copyright 2014 BSI. All rights reserved. 41
42
43 FAQs Regarding EN ISO 14971: If our procedures were written to comply with ISO 14971:2007, do we have to change them? The normative part of the standard is identical. Most likely. The Z Annexes (ZA, ZB, and ZC) discuss deviations from the standard relative to the ability to comply with the MDD, AIMD, and IVDD. Therefore, additional steps must usually be taken in order to demonstrate compliance with the Essential Requirements (ERs) within the directives. In many cases, changes will need to be made to address the following (at a minimum): ensuring that ALL risks are reduced as far as possible; a risk/benefit analysis was conducted and considers all individual and overall risks; ALL risks have appropriate controls and the risks have been designed out if possible (MDD & IVDD only); risks have not been inappropriately reduced by labeling alone (MDD & IVDD only). Copyright 2014 BSI. All rights reserved. 43
44 FAQs Regarding EN ISO 14971: Isn t the point of risk management to focus on the big risks? It is true that risk management activities have historically focused on identifying and reducing risks that have been unacceptable or were significant. However, the directives do not make distinctions in risk levels and simply refer to reducing ALL risks. Therefore, based on current thinking, in order to comply with the directives, the focus should be on reducing ALL risks. 3. As a manufacturer, how can we not take into account any economic considerations? It is understood that all risks cannot be eliminated and that the manufacturer is bound by the level of current technology and the state-of-the-art. It is also understood that a single device may not be intended for all individuals / applications and could be limited to certain populations. Therefore, the expectation is that if there are means to reduce risks for the intended use by available technologies and the state-of-the-art, that these measures should be taken. As risk management is also an active process that should continue to be evaluated post-production, if new technologies or the state-of-the-art change after the device was released, the question as to whether ALL risks have been reduced as far as possible should continue to be evaluated. Copyright 2014 BSI. All rights reserved. 44
45 FAQs Regarding EN ISO 14971: Our QMS auditor said our RM procedures were effective and met EN ISO 14971:2012. We don t understand why the Technical Reviewer gave us a non-conformity for risk management. The primary responsibility for the QMS auditor is to review the manufacturer s procedures to ensure that they meet ISO and to sample records to ensure that the procedures have been executed appropriately. On the other hand, the primary responsibility for the Technical Reviewer is to review the output of the QMS system (i.e. Technical Documentation) and ensure that the product conforms to the applicable directive. Therefore, it is possible for the procedures and some of the records to have been updated to ensure compliance with EN ISO 14971:2012 but that the file(s) being reviewed by the Technical Reviewer do not demonstrate compliance with the directive. Copyright 2014 BSI. All rights reserved. 45
46 FAQs Regarding EN ISO 14971: Do we have to change all our historical RM files or can we just address new product development and product changes? All files should be reviewed (based on a risk commensurate plan) to ensure that they comply with the directives and updated accordingly. Demonstration of compliance is expected. 6. Does BSI expect a line-by-line risk/benefit analysis? No. The manufacturer is expected to consider all individual risks and the overall risk in a risk / benefit analysis. How that is done is up to the manufacturer. BSI expects that the manufacturer documents (procedurally) how they intend to do this and executes this procedure. Copyright 2014 BSI. All rights reserved. 46
47 FAQs Regarding EN ISO 14971: We have used a no-train, no-sale policy to reduce the risk of issues. Could this be used to reduce the probability of occurrence? Potentially. Deviation 7 only addresses not using information given to the users (i.e. in the IFU or through training) to reduce risks further. Therefore, if the training program is being used to teach the user proper operation of the device, this would most likely not be considered providing information to address residual risk. However, if this is being used as a forum to convey residual risk about the device, this would not be considered an appropriate way to mitigate risk. Copyright 2014 BSI. All rights reserved. 47
48 FAQs Regarding EN ISO 14971: BSI agreed at the last design exam certification review that the RM files were acceptable and met the ERs. The device has not changed. Why is this not still acceptable? Harmonized standards are used as a method to convey state-of-the-art thinking on how compliance with the clauses of the standard confer a presumption of conformity with the associated directive and EFTA regulations. The Z Annexes explain to which requirements, under which conditions, and to what extent presumption of conformity can be claimed. Publishing of EN ISO 14971:2012 changed the state-of-the art view of these conditions. Therefore, while previous submissions may have allowed full presumption of conformity with the directives, this is no longer possible unless additional information is provided to address the deviations. Copyright 2014 BSI. All rights reserved. 48
ISO 14971: Overview of the standard
FDA Medical Device Industry Coalition ISO 14971: Overview of the standard Risk Management Through Product Life Cycle: An Educational Forum William A. Hyman Department of Biomedical Engineering Texas A&M
More informationMedical Device Software Do You Understand How Software is Regulated?
Medical Device Software Do You Understand How Software is Regulated? By Gregory Martin Agenda Relevant directives, standards, and guidance documents recommended to develop, maintain, and validate medical
More informationRisk Assessment for Medical Devices. Linda Braddon, Ph.D. Bring your medical device to market faster 1
Risk Assessment for Medical Devices Linda Braddon, Ph.D. Bring your medical device to market faster 1 My Perspective Work with start up medical device companies Goal: Making great ideas into profitable
More informationBSI Road Show: September 8 th to 15 th, 2014
BSI Road Show: September 8 th to 15 th, 2014 Post Market Surveillance (including PMCF): common non compliances Ibim Tariah Ph.D Technical Director, Healthcare Solutions Itoro Udofia Ph.D Global Head, Orthopaedics
More informationMedical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day
Medical Devices Notified Bodies and the CE certification Process for Medical Devices European Surgical Robotics Demonstration Day 27 th March 2014, Leuven, Belgium 1 Bart Mersseman Product Manager Medical
More informationReporting Changes to your Notified Body
Reporting Changes to your Notified Body Vicky Medley - Head of QMS, Medical Devices September 2015 1) Requirements & Guidance 2) Reporting Changes - What, When, Why & How 3) Some examples 4) Summary &
More informationVigilance Reporting. Vicky Medley - Head of QMS, Medical Devices. September 2015. Copyright 2015 BSI. All rights reserved.
Vigilance Reporting Vicky Medley - Head of QMS, Medical Devices September 2015 2 Why? 3 protecting and improving public health https://www.gov.uk/government/organisations/medicines-and-healthcareproducts-regulatory-agency/about
More informationClinical evaluation Latest development in expectations EU and USA
Clinical evaluation Latest development in expectations EU and USA Medical Devices: staying ahead of regulatory developments Gert Bos BSI Israel 22 April - Herzliya Copyright 2012 BSI. All rights reserved.
More informationGUIDELINES ON MEDICAL DEVICES EVALUATION OF CLINICAL DATA : A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Pressure equipment, medical devices, metrology MEDDEV. 2.7.1 April 2003 GUIDELINES
More informationWant to know more about the Notified Body?
NBG/V 2/07/14 BSI Notified Body (0086) Kitemark Court Davy Avenue Knowlhill Milton Keynes MK5 8PP United Kingdom T: +44 845 080 9000 E: eu.medicaldevices@bsigroup.com W: medicaldevices.bsigroup.com Want
More informationGUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES
GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES Foreword This guidance document is informative and advisory and has no legal authority. Individual national enforcement authorities are bound
More informationwww.transition-support.com
Can we include all products and services in the QMS but limit the scope of registration? According to ISO/TC 176/SC 2/N 524, organizations are not obliged to include all the products that it provides within
More informationMedical Device Software Standards for Safety and Regulatory Compliance
Medical Device Software Standards for Safety and Regulatory Compliance Sherman Eagles +1 612-865-0107 seagles@softwarecpr.com www.softwarecpr.com Assuring safe software SAFE All hazards have been addressed
More informationInformation supplied by the manufacturer with medical devices
Irish Standard I.S. EN 1041:2008 Information supplied by the manufacturer with medical devices NSAI 2008 No copying without NSAI permission except as permitted by copyright law. I.S. EN 1041:2008 Incorporating
More informationRisk Management in IEC 60601-1 3 rd Edition. Presented by Alberto Paduanelli Medical Devices Lead Auditor, MHS-UK, TÜV SÜD Product Service
Risk Management in IEC 60601-1 3 rd Edition Presented by Alberto Paduanelli Medical Devices Lead Auditor, MHS-UK, TÜV SÜD Product Service General Information Time of presentation: 50-60 min. Questions
More informationRisk Assessment Tools for Identifying Hazards and Evaluating Risks Associated with IVD Assays
Risk Assessment Tools for Identifying Hazards and Evaluating Risks Associated with IVD Assays Robert C. Menson, PhD AACC Annual Meeting Philadelphia, PA 22 July 2003 What Risks Must Be Managed? Risk to
More informationGUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health technology and Cosmetics MEDDEV 2.7/1 revision 4 June 2016 GUIDELINES
More informationUNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
UNDERSTANDING THE EC DIRECTIVE 98/79/EC ON IN VITRO DIAGNOSTIC MEDICAL DEVICES A WHITE PAPER ON THE REQUIREMENTS, REGULATIONS AND OPPORTUNITIES CONTAINED IN EC DIRECTIVE 98/79/EC AND A BRIEF COMPARISON
More informationTitle: Basic Principles of Risk Management for Medical Device Design
Title: Basic Principles of Risk Management for Medical Device Design WHITE PAPER Author: Ganeshkumar Palanichamy Abstract Medical devices developed for human application are used for diagnostic or treatment
More informationSpace project management
ECSS-M-ST-80C Space project management Risk management ECSS Secretariat ESA-ESTEC Requirements & Standards Division Noordwijk, The Netherlands Foreword This Standard is one of the series of ECSS Standards
More informationHow To Know If A Mobile App Is A Medical Device
The Regulation of Medical Device Apps Prepared for West of England Academic Health Science Network and University of Bristol June 2014 June 2014 1 Table of Contents 1 Purpose...3 2 Scope...3 3 The Regulation
More informationGuidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System
NBOG s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System 1 Introduction The
More informationQuality Risk Management - The Medical Device Experience. Niamh Nolan Principal Design Assurance Engineer Boston Scientific
Quality Risk Management - The Medical Device Experience Niamh Nolan Principal Design Assurance Engineer Boston Scientific Agenda Intent of Risk Management (RM) and Associated Regulations Overview of RM
More informationMedical Software Development. International standards requirements and practice
Medical Software Development International standards requirements and practice Food and Drug Administration What? A public health agency Why? Protect American consumers How? By enforcing the Federal Food,
More informationFINAL DOCUMENT. Implementation of risk management principles and activities within a Quality Management System. The Global Harmonization Task Force
GHTF/SG3/N15R8 FINAL DOCUMENT Title: Implementation of risk management principles and activities within a Quality Management System Authoring Group: GHTF Study Group 3 Endorsed by: The Global Harmonization
More information9100:2016 Series of Standards Frequently Asked Questions (FAQs)
Frequently Asked Questions (FAQs) In developing this list of Frequently Asked Questions (FAQ's) for the 9100:2016 Series revisions, input has been obtained from experts and users of the standard from around
More informationMedical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules?
Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? CEMO Congress, Paris, February 3rd, 2011 Dr. Martine Dehlinger-Kremer Vice President Global Regulatory Affairs Agenda
More informationWHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE
WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE White paper produced by Maetrics For more information, please contact global sales +1 610 458 9312 +1 877 623 8742 globalsales@maetrics.com
More informationManual for ITC's clients, 2013. Conformity assessment of ACTIVE IMPLANTABLE MEDICAL DEVICES pursuant to Council Directive 90/385/EEC
Manual for ITC's clients, 2013 Conformity assessment of ACTIVE IMPLANTABLE MEDICAL DEVICES pursuant to Council Directive 90/385/EEC Institute for Testing and Certification, inc., Czech Republic, EU 1.
More informationRECALLS in EUROPE. Past, present, near & further future. Gert Bos BSI Medcon May 2012
RECALLS in EUROPE Past, present, near & further future Gert Bos BSI Medcon May 2012 A C P D Vigilance, vigilant: Continually watchful or on guard; always prepared for possible danger Content 2 Current
More informationPROPOSED DOCUMENT. Quality management system Medical devices Nonconformity Grading System for Regulatory Purposes and Information Ex-change
AHWP/WG3/P001:2013 PROPOSED DOCUMENT Title: Quality management system Medical devices Nonconformity Grading System for Regulatory Purposes and Information Ex-change Author: AHWP Work Group 3 Date: 13 November
More informationSafety Risk Management in RT: A Software Manufacturer Perspective
Safety Risk Management in RT: A Software Manufacturer Perspective Jim Schewe, Ph.D. Philips Radiation Oncology Systems AAPM Spring Clinical Meeting March 16, 2014 1 Learning Objectives For the session
More informationMed-Info. Council Directive 93/42/EEC on Medical Devices. TÜV SÜD Product Service GmbH
Med-Info International expert information for the Medical Device industry Council Directive 93/42/E on Medical Devices Practice-oriented summary of the most important aspects and requirements contained
More informationCE Marking and Technical Standardisation
GAMBICA Technical Guide CE Marking and Technical Standardisation Guidelines for application to Electrical Power Drive Systems Edition 4 : 2015 CE Marking and Technical Standardisation Guidelines for application
More informationFMEA and FTA Analysis
FMEA and FTA Analysis Why it is Coming to Your Hospital and Your Laboratory Tina A. Krenc Director, R&D Phase Systems Abbott Laboratories 1 Agenda Background on requirements for risk management Tools to
More informationISO 9001:2000 Gap Analysis Checklist
ISO 9001:2000 Gap Analysis Checklist Type: Assessor: ISO 9001 REQUIREMENTS STATUS ACTION/COMMENTS 4 Quality Management System 4.1 General Requirements Processes needed for the quality management system
More informationMedical Devices: CE Marking Step-by Step
Medical Devices: CE Marking Step-by Step Sylvia Mohr Standards Specialist U.S. Mission to the European Union 1 Introduction CE marking in 8 Steps Overview intended purpose - technical documentation classification
More informationCAPA - the importance of data analysis
CAPA - the importance of data analysis Presented by: Sue Jacobs QMS Consulting, Inc. 1 847 359 4456 sue@qmsconsultant.com QMS Consulting, Inc. 2007 1 Topics Regulatory Requirements Design Controls and
More informationQUALITY RISK MANAGEMENT (QRM): A REVIEW
Lotlikar et al Journal of Drug Delivery & Therapeutics; 2013, 3(2), 149-154 149 Available online at http://jddtonline.info REVIEW ARTICLE QUALITY RISK MANAGEMENT (QRM): A REVIEW Lotlikar MV Head Corporate
More informationISO 13485:201x What is in the new standard?
ISO 13485:201x What is in the new standard? Eric Finegan, Quality Mgr, BTE Technologies, Inc. 2015-09-10 1 Presentation Slides This slide deck is the presentation performed on 2015-09-10. A more detailed
More informationISO 14971:2012 Ensuring Compliance to Annex Z Requirements
ISO 14971:2012 Ensuring Compliance to Annex Z Requirements David Amor, MS, CQA Managing Partner MEDgineering www.medgineering.com david@medgineering.com Agenda Risk Management Best Prac8ces Overview ISO
More informationControlling Risks Risk Assessment
Controlling Risks Risk Assessment Hazard/Risk Assessment Having identified the hazards, one must assess the risks by considering the severity and likelihood of bad outcomes. If the risks are not sufficiently
More informationIntroduction into IEC 62304 Software life cycle for medical devices
Introduction into IEC 62304 Software life cycle for medical devices Christoph Gerber 4. September 2008 SPIQ 9/5/2008 1 Agenda Current Picture Regulatory requirements for medical device software IEC 62304
More informationSupplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002)
Supplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002) Supplier: Plant/Location: Date: Audit Team: Scope of Audit: Number of C.A.R. s: Corrective Action Due: Potential suppliers
More informationQuality Risk Management ICH Q9 & ISO 14971. Presented by Michael Kerr 11 th November 2011
Quality Risk Management ICH Q9 & ISO 14971 Presented by Michael Kerr 11 th November 2011 Agenda Risk Concept QRM Fundamentals Regulatory Expectations Warning Letters / Observations Application of QRM Introduction:
More informationQuality Management System Certification. Understanding Quality Management System (QMS) certification
Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality
More informationDesign Verification The Case for Verification, Not Validation
Overview: The FDA requires medical device companies to verify that all the design outputs meet the design inputs. The FDA also requires that the final medical device must be validated to the user needs.
More informationGuidance for Industry: Quality Risk Management
Guidance for Industry: Quality Risk Management Version 1.0 Drug Office Department of Health Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. What is risk?... 4 5. Integrating
More informationPABIAC Safety-related Control Systems Workshop
Health and and Safety Executive PABIAC Safety-related Control Systems Workshop KEY STANDARDS FOR ELECTRICAL & FUNCTIONAL SAFETY OF PAPERMAKING MACHINES: APPLICATION & USE Steve Frost HM Principal Electrical
More informationFailure Analysis Methods What, Why and How. MEEG 466 Special Topics in Design Jim Glancey Spring, 2006
Failure Analysis Methods What, Why and How MEEG 466 Special Topics in Design Jim Glancey Spring, 2006 Failure Analysis Methods Every product or process has modes of failure. An analysis of potential failures
More informationBringing Legacy Medical Devices into Usability Compliance. Shannon Clark 4/29/2015
Bringing Legacy Medical Devices into Usability Compliance Shannon Clark 4/29/2015 Agenda What is a legacy device? Background on Usability Engineering Standards What is the roadmap for bringing legacy devices
More informationDeviation Handling and Quality Risk Management
Deviation Handling and Quality Risk Management A note for guidance for the manufacture of prequalified vaccines for supply to United Nations agencies July, 2013 Vaccine Quality and Regulations (VQR), Essential
More informationBSI Unannounced Audits
BSI Unannounced Audits Frequently Asked Questions (FAQs) BSI Group Kitemark Court, Davy Avenue Knowlhill, Milton Keynes MK5 8PP, United Kingdom T: +44 845 080 900 Certification.sales@bsigroup.com bsigroup.com
More informationSafety Regulation Group SAFETY MANAGEMENT SYSTEMS GUIDANCE TO ORGANISATIONS. April 2008 1
Safety Regulation Group SAFETY MANAGEMENT SYSTEMS GUIDANCE TO ORGANISATIONS April 2008 1 Contents 1 Introduction 3 2 Management Systems 2.1 Management Systems Introduction 3 2.2 Quality Management System
More informationPreparing yourself for ISO/IEC 27001 2013
Preparing yourself for ISO/IEC 27001 2013 2013 a Vintage Year for Security Prof. Edward (Ted) Humphreys (edwardj7@msn.com) [Chair of the ISO/IEC and UK BSI Group responsible for the family of ISMS standards,
More informationALL Medical Devices regardless of Classification
TÜV SÜD Product Service GmbH 30.09.2013 http://omowizard.files.wordpress.com/2010/07/fit-for-purpose.jpg Folie 1 Medical Device Requirements for Clinical Data Dir. 2007/47/EC Which medical devices require
More informationGUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
Foreword GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES These guidance notes do not aim to be a definite interpretation of National Laws and/or regulations and are for guidance purpose only.
More informationThe New Paradigm for Medical Device Safety. Addressing the Requirements of IEC 60601-1 Edition 3.1
The New Paradigm for Medical Device Safety Addressing the Requirements of IEC 60601-1 Edition 3.1 Medical devices play a vital role in the diagnosis and treatment of most health-related conditions, and
More informationGENERIC STANDARDS CUSTOMER RELATIONSHIPS FURTHER EXCELLENCE CUSTOMISED SOLUTIONS INDUSTRY STANDARDS TRAINING SERVICES THE ROUTE TO
PROCESSES SUPPLY CHAIN SKILLED TALENT CUSTOMER RELATIONSHIPS FURTHER EXCELLENCE GENERIC STANDARDS INDUSTRY STANDARDS CUSTOMISED SOLUTIONS TRAINING SERVICES THE ROUTE TO ISO 9001:2015 FOREWORD The purpose
More informationISO 14001 & ISO 18001 Legal Compliance Know Your Risk - Reduce your Risk"
American Society For Quality -Toronto Section ISO 14001 & ISO 18001 Legal Compliance Know Your Risk - Reduce your Risk" Copyright: Coudenys Management Systems Inc. RISK DEFINED Occurrence of the event
More informationISO 9001:2008 Quality Management System Requirements (Third Revision)
ISO 9001:2008 Quality Management System Requirements (Third Revision) Contents Page 1 Scope 1 1.1 General. 1 1.2 Application.. 1 2 Normative references.. 1 3 Terms and definitions. 1 4 Quality management
More informationISO Revisions Whitepaper
ISO Revisions ISO Revisions Whitepaper What is the difference between a procedures and a process approach? Approaching change Process vs procedures: What does this mean? The concept of process management
More informationINTRODUCTION TO ISO 9001 REVISION - COMMITTEE DRAFT
INTRODUCTION TO ISO 9001 REVISION - COMMITTEE DRAFT AGENDA Introduction Annex SL Changes to ISO 9001 Future Development How SGS can support you 2 INTRODUCTION ISO 9001 Revision Committee Draft Issued 2013
More informationISO 9001:2008 Internal Audit & Gap Analysis Checklist
Page 1 of 54 Audit Date: Audit Description: Lead Auditor: Audit Team Members: ISO 9001:2008 Auditable Clauses (Tick those to be evaluated during this audit) Each auditor should complete the section of
More informationHow To Write Software
1 Medical Device Software - Software Life Cycle Processes IEC 62304 2 Credits John F. Murray Software Compliance Expert U.S. Food and Drug Administration Marcie R. Williams Medical Device Fellow Ph.D.
More informationGUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EUROPEAN COMMISSION DG Health and Consumers (SANCO) Directorate B-Consumer Affairs Unit B2- Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDDEV 2.12-1 rev 8 January 2013 GUIDELINES
More informationGUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EUROPEAN COMMISSION DG ENTERPRISE AND INDUSTRY Directorate F-Consumer Good Unit F3- Cosmetic and Medical Devices MEDICAL DEVICES: Guidance document MEDDEV 2.12-1 rev 5 April 2007 GUIDELINES ON A MEDICAL
More informationImproved Utilization of Self-Inspection Programs within the GMP Environment A Quality Risk Management Approach
Improved Utilization of Self-Inspection Programs within the GMP Environment A Quality Risk Management Approach Barbara Jeroncic Self-inspection is a well-established and vital part of the pharmaceutical
More informationSoftware-based medical devices from defibrillators
C O V E R F E A T U R E Coping with Defective Software in Medical Devices Steven R. Rakitin Software Quality Consulting Inc. Embedding defective software in medical devices increases safety risks. Given
More informationProcess Mapping and Process- Based Internal Audits
Process Mapping and Process- Based Internal Audits Presented by Shannon Craddock of Perry Johnson Registrars, Inc. September 21, 2011 Today s Topics Why Are We Doing This? Process Terminology Process Mapping
More informationQuality Risk Management
PS/INF 1/2010 * * Quality Risk Management Quality Risk Management Implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S Document > Authors: L. Viornery (AFSSAPS) Ph.
More informationISO-9001:2000 Quality Management Systems
ISO-9001:2000 Quality Management Systems REQUIREMENTS 10/10/2003 ISO-9001:2000 Requirements 1 Process Based Approach C U S MANAGEMENT RESPONSIBILITY RESOURCE MANAGEMENT C U S T O M Requirements PRODUCT
More informationISO 9001:2000 AUDIT CHECKLIST
ISO 9001:2000 AUDIT CHECKLIST No. Question Proc. Ref. Comments 4 Quality Management System 4.1 General Requirements 1 Has the organization established, documented, implemented and maintained a quality
More informationDocument: ISO/TC 176/SC 2/N 1147
ISO 2013 All rights reserved Document: ISO/TC 176/SC 2/N 1147 Secretariat of ISO/TC 176/SC 2 Date: 3 June 2013 To the Members of ISO/TC 176/SC 2 - Quality Management and Quality Assurance/ Quality Systems
More informationIVD Regulation Overview. Requirements to Assure Quality & Effectiveness
IVD Regulation Overview Requirements to Assure Quality & Effectiveness CLIAC Jan. 2002 Statutory and Regulatory Requirements Statute: Food, Drug, and Cosmetic Act Food and Drugs Act of 1906 Food and Drug
More informationV1.0 - Eurojuris ISO 9001:2008 Certified
Risk Management Manual V1.0 - Eurojuris ISO 9001:2008 Certified Section Page No 1 An Introduction to Risk Management 1-2 2 The Framework of Risk Management 3-6 3 Identification of Risks 7-8 4 Evaluation
More informationISO 9001:2008 Audit Checklist
g GE Power & Water ISO 9001:2008 Audit Checklist Organization Auditor Date Page 1 Std. 4.1 General s a. Are processes identified b. Sequence & interaction of processes determined? c. Criteria for operation
More informationISO 9001 : 2008 QUALITY MANAGEMENT SYSTEM AUDIT CHECK LIST INTRODUCTION
INTRODUCTION What auditors should look for: the items listed in these headings that the ISO requirement is met that the requirement is met in the manner described in the organization's documentation Page
More informationHow to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters
environmental failure analysis & prevention health technology development How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters Kevin L. Ong, Ph.D., P.E. Managing
More informationICH guideline Q10 on pharmaceutical quality system
September 2015 EMA/CHMP/ICH/214732/2007 Committee for Human Medicinal Products Step 5 Transmission to CHMP May 2007 Transmission to interested parties May 2007 Deadline for comments November 2007 Final
More informationQuality Risk Management in Pharmaceutical Industry: A Review
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.6, No.3, pp 908-914, July-Aug 2014 Quality Risk Management in Pharmaceutical Industry: A Review V Vijayakumar Reddy*,
More informationMedical Device Reporting (MDR) Requirements the New FDA Draft Guidance
Medical Device Reporting (MDR) Requirements the New FDA Draft Guidance February 27, 2014 Jeffrey K. Shapiro (202) 737-9633 jshapiro@hpm.com 1 Essential Requirements n Submit MDR reportable events to FDA
More informationICH Q9 Quality Risk Management - an industry view. Peter H. Gough, Eli Lilly and Company
ICH Q9 Quality Risk Management - an industry view Peter H. Gough, Eli Lilly and Company Contents How did we get here? FDA 21 st Century GMP Initiative ICH activity Introduction to risk management Links
More informationISO 9001:2015 QUALITY MANAGEMENT SYSTEM ***** ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM
ISO 9001:2015 QUALITY MANAGEMENT SYSTEM ***** ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM ***** OHSAS 18001:2007 OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM ***** QMS-EMS-OHS MANUAL Your Company
More informationDesigning an Effective Risk Matrix
Designing an Effective Risk Matrix HENRY OZOG INTRODUCTION Risk assessment is an effective means of identifying process safety risks and determining the most cost-effective means to reduce risk. Many organizations
More informationPreparation for ISO 45001 OH&S Management Systems
Preparation for ISO 45001 OH&S Management Systems HEALTH & SAFETY MANAGEMENT QUALITY MANAGEMENT ACCESSIBILITY ENVIRONMENTAL MANAGEMENT ENERGY MANAGEMENT ISO 45001 TIMELINE ISO project committee ISO PC
More informationSafety Management Systems (SMS) guidance for organisations
Safety and Airspace Regulation Group Safety Management Systems (SMS) guidance for organisations CAP 795 Published by the Civil Aviation Authority, 2014 Civil Aviation Authority, CAA House, 45-59 Kingsway,
More informationDNV GL Assessment Checklist ISO 9001:2015
DNV GL Assessment Checklist ISO 9001:2015 Rev 0 - December 2015 4 Context of the Organization No. Question Proc. Ref. Comments 4.1 Understanding the Organization and its context 1 Has the organization
More informationMedia fills Periodic performance qualification (Re-Validation)
Media fills Periodic performance qualification (Re-Validation) Minimum number of Simulations Number of units Contaminated Units Action a Two per Year (Retrospective & Prospective Validation) < 5000 5000
More informationTG 47-01. TRANSITIONAL GUIDELINES FOR ISO/IEC 17021-1:2015, ISO 9001:2015 and ISO 14001:2015 CERTIFICATION BODIES
TRANSITIONAL GUIDELINES FOR ISO/IEC 17021-1:2015, ISO 9001:2015 and ISO 14001:2015 CERTIFICATION BODIES Approved By: Senior Manager: Mpho Phaloane Created By: Field Manager: John Ndalamo Date of Approval:
More information4. Critical success factors/objectives of the activity/proposal/project being risk assessed
ARTC Risk Management Work Instruction 2: 1. Conduct Risk Assessment Workshop This Work Instruction provides general guidelines for conducting a generic Risk Assessment workshop. The instructions supplement
More informationOperating instructions Diffuse reflection sensor with background suppression O1D101 O1D104 706114 / 00 01 / 2012
Operating instructions Diffuse reflection sensor with background suppression O1D101 O1D104 706114 / 00 01 / 2012 Contents 1 Preliminary note 3 1.1 Symbols used 3 1.2 Warning signs used 3 2 Safety instructions
More informationSafety and functional safety A general guide
Safety and functional safety A general guide This document is an informative aid only. The information and examples given are for general use only. They do not describe all the necessary details for implementing
More informationPreparing for Unannounced Inspections from Notified Bodies
Preparing for Unannounced Inspections from Notified Bodies Europe has introduced further measures for unannounced audits of manufacturers by notified bodies. With this in mind, James Pink, VP Europe-Health
More informationQuality Management System Certification. Understanding Quality Management System (QMS) certification
Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality
More informationQuality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle
Quality Risk Management 11 November 2011 Galway, Ireland Quality Risk Management The Pharmaceutical Experience Ann O Mahony Quality Assurance Specialist Pfizer Biotech Grange Castle Overview Regulatory
More informationBEST PRACTICE FOR THE DESIGN AND OPERATION OF HIGH HAZARD SITES
BEST PRACTICE FOR THE DESIGN AND OPERATION OF HIGH HAZARD SITES Lyn Fernie and Jo Fearnley AK EHS & Risk, Aker Kvaerner Engineering Services Ltd, Ashmore House, Stockton on Tees, TS18 3RE. The idea of
More informationRisk Analysis Fanless Slim Medical Panel PC, models xxxx-onyx-2121dtyxxxxxxx
Risk Analysis Fanless Slim Medical Panel PC, models xxxx-onyx-2121dtyxxxxxxx Company: Creation Date: 2013-08-22 Abbreviation: Project Number: Project : Version Number: Version : Life Cycle Phase: ONYX-2121DT
More information