Compliance-oriented development of innovative medical devices from research to market
|
|
|
- Maria Perry
- 9 years ago
- Views:
Transcription
1 Compliance-oriented development of innovative medical devices from research to market Workshop at BRI Pontedera, Italy Ovesco Endoscopy AG Tuebingen, Germany Dr. Sebastian Schostek
2 TRL and the valley of death Why regulations? Some basics The how-to
3 TRL and the valley of death Compliance Workshop Valley of death 3
4 TRL and the valley of death Compliance Workshop Valley of death 4 Resources spent Resources required
5 TRL and the valley of death Why regulations? Some basics The how-to
6 Innovation in medical technologies 6 Disruptive innovations cause the interface between engineering and medicine to oscillate this drives the advancement of a new field. Here: Minimally invasive surgery. Engineering: TECHNOLOGY Medicine: TECHNIQUE Technology push through a novel technique New technology requires the development of novel techniques Technology push through a novel technique Kurt Semm 1980: The advent of Minimally Invasive Surgery (MIS)
7 Innovation in medical technologies 7 The driving cycle consist of four essential steps. An advancement in one discipline requires and advancement in the other (steps 1, 3). Decisive is the purposeful translation between the fields (steps 2, 4). Engineering: TECHNOLOGY Consequence: Increased level of complexity and difficulty 2 Motivation: Facilitate / ease procedures through technology Consequence: Increased level of complexity and difficulty Medicine: TECHNIQUE Motivation: Improve safety, efficacy and patient comfort Consequence: New technique related paradigms (e.g. user interface) 4 Motivation: Improve safety, efficacy and patient comfort Kurt Semm 1980: The advent of Minimally Invasive Surgery (MIS)
8 8 Innovation in medical technologies Engineering: TECHNOLOGY Medicine: TECHNIQUE Wilhelm Conrad Röntgen 1895 Learnings: In the field of medical technology, the emergence of innovations realies on both engineers and doctors to the same extent (symmetrical). An innovation can be driven by either engineering or medicine. Decisive for exploitation is to purposefully act at the interface between both fields. Engineering: TECHNOLOGY Medicine: TECHNIQUE Kurt Semm 1980
9 Innovation in medical technologies: Stakeholders 9 Politics and authorities Medical device industry Market (Naiv population) Interface Healthcare providers Payers
10 What s so special about medical devices? 10 Industrial product, e.g. smartphone It is safe It works It is easy to use Service is provided Good guidance provided Price Colour Design Medical device, e.g. EndoVESPA It is safe It works It is easy to use Service is provided Good guidance provided Price Colour Design
11 TRL and the valley of death Why regulations? Some basics The how-to
12 Definition of a medical device (see MDD 93/42/EEC) 12 Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
13 Compliance It s all about requirements 13 Directives and standards Top-down requirements Design input Medical device development Notified body Market Design input Bottom-up requirements User requirements, risk management file output, usability file output, manufacturability, marketing, etc.
14 Compliance It s all about requirements 14 Directives and standards Top-down requirements Design input Medical device development Notified body Market Design input Bottom-up requirements User requirements, risk management file output, usability file output, manufacturability, marketing, etc.
15 Directives Why regulations? Compliance Workshop Compliance Top-down requirements 15 Directives: MDD 93/42 or AIMD 90/385 or IVD 98/79 MDD: Medical Device Directive 93/42/EEC Applies to all other Medical devices Includes classification AIMD: Active implantable medical devices 90/385/EEC Applies to AIMD only No classification included IVD: In-vitro diagnostic medical devices 98/79/EC Applys to IVD only No classification included
16 Compliance Top-down requirements 16 MDD: Medical Device Directive 93/42/EEC Article 1: Definitions, scope Article 2: Placing on the market and putting into service Article 3: Essential requirements Article 4: Free movement, devices intended for special pruposes Article 5: Reference to standards Article 6: Committee on Standards and Technical Regulations Article 7: The Committee Article 8: Safeguard claus Article 9: Classification Article 10: Information on incidents occuring following placing of devices on the market Article 11: Conformity assessment procedures Article 12: Particular procedure for systems and procedure packs and procedure for sterilisation Article 13: Decision with regard to classification and derogation clause Article 14: Registration of persons responsible for placing devices on the market Article 15: Clinical investigation Article 16: Notified bodies Article 17: CE marking Article 18: Wrongly affixed CE marking Article 19: Decision in respect of refusal or restriction Article 20: Confidentiality Article 21: Repeal and amendment of Directives Article 22: Implementation, transitional provisions Annex I: Essential requirements Annex II: EC declaration of conformity Annex III: EC type-examination Annex IV: EC verification Annex V: EC declaration of conformity (production quality assurance) Annex VI: EC declaration of conformity (product quality assurance) Annex VII: EC declaration of conformity Annex VIII: Statement concerning devices for special purposes Annex IX: Classification criteria Annex X: Clinical evaluation Annex XI: Criteria to be met for the designation of notified bodies Annex XII: CE marking of conformity
17 Compliance Top-down requirements 17 MDD: Medical Device Directive 93/42/EEC Article 1: Definitions, scope Article 2: Placing on the market and putting into service Article 3: Essential requirements Article 4: Free movement, devices intended for special pruposes Article 5: Reference to standards Article 6: Committee on Standards and Technical Regulations Article 7: The Committee Article 8: Safeguard claus Article 9: Classification Article 10: Information on incidents occuring following placing of devices on the market Article 11: Conformity assessment procedures Article 12: Particular procedure for systems and procedure packs and procedure for sterilisation Article 13: Decision with regard to classification and derogation clause Article 14: Registration of persons responsible for placing devices on the market Article 15: Clinical investigation Article 16: Notified bodies Article 17: CE marking Article 18: Wrongly affixed CE marking Article 19: Decision in respect of refusal or restriction Article 20: Confidentiality Article 21: Repeal and amendment of Directives Article 22: Implementation, transitional provisions Annex I: Essential requirements Annex II: EC declaration of conformity Annex III: EC type-examination Annex IV: EC verification Annex V: EC declaration of conformity (production quality assurance) Annex VI: EC declaration of conformity (product quality assurance) Annex VII: EC declaration of conformity Annex VIII: Statement concerning devices for special purposes Annex IX: Classification criteria Annex X: Clinical evaluation Annex XI: Criteria to be met for the designation of notified bodies Annex XII: CE marking of conformity
18 Compliance Top-down requirements 18 MDD: Medical Device Directive 93/42/EEC Article 1: Definitions, scope Article 2: Placing on the market and putting into service Article 3: Essential requirements Article 4: Free movement, devices intended for special pruposes Article 5: Reference to standards Article 6: Committee on Standards and Technical Regulations Article 7: The Committee Article 8: Safeguard claus Article 9: Classification Article 10: Information on incidents occuring following placing of devices on the market Article 11: Conformity assessment procedures Article 12: Particular procedure for systems and procedure packs and procedure for sterilisation Article 13: Decision with regard to classification and derogation clause Article 14: Registration of persons responsible for placing devices on the market Article 15: Clinical investigation Article 16: Notified bodies Article 17: CE marking Article 18: Wrongly affixed CE marking Article 19: Decision in respect of refusal or restriction Article 20: Confidentiality Article 21: Repeal and amendment of Directives Article 22: Implementation, transitional provisions Annex I: Essential requirements Annex II: EC declaration of conformity Annex III: EC type-examination Annex IV: EC verification Annex V: EC declaration of conformity (production quality assurance) Annex VI: EC declaration of conformity (product quality assurance) Annex VII: EC declaration of conformity Annex VIII: Statement concerning devices for special purposes Annex IX: Classification criteria Annex X: Clinical evaluation Annex XI: Criteria to be met for the designation of notified bodies Annex XII: CE marking of conformity
19 Compliance Top-down requirements 19 Harmonized standards For a start: focus on standards with relevance on construction and design
20 Compliance It s all about requirements 20 Directives and standards Top-down requirements Design input Medical device development Notified body Market Design input Bottom-up requirements User requirements, risk management file output, usability file output, manufacturability, marketing, etc.
21 Compliance Bottom-up requirements 21 Risk management file User requirements EN ISO Medical device, e.g. EndoVESPA It is safe It works Usability file EN It is easy to use Service is provided Good guidance provided Manufacturer certification EN ISO Manufacturability Marketing Price Colour Design
22 TRL and the valley of death Why regulations? Some basics The how-to
23 The how-to - Compliance Workshop Methodology: Sources (non-exclusive) 23 Europe: EN ISO Chapter 7.3 For programmable electrical medical systems (PEMS): EN (3 rd edition) Chapter 14.4 For medical software: EN FDA: CFR Design controls Available online (google CFR )
24 The how-to - Compliance Workshop Methodology: Implementation Start Planning Project plan User needs A A normative and regulatory requirements User requirements Application validation plan Design Input Product requirements Test plan Execution A Risk management Usability Verification and validation Outputs Manufacturability Test reports Specifications Transfer into production List of applicable Standards Application validation Manufacturing documentation Conformity evaluation End Riskmanagement file Validation reports Technical documentation Usability file Manufacturability input
25 The how-to - Compliance Workshop Methodology: Implementation 25 Start Planning A Project plan normative and regulatory requirements User needs User requirements Application validation plan A Design Input Product requirements Test plan Execution Iterative development cycle A Risk management Usability Verification and validation Outputs Manufacturability Test reports Specifications Transfer into production List of applicable Standards Application validation Manufacturing documentation Conformity evaluation End Riskmanagement file Validation reports Technical documentation Usability file Manufacturability input
26 Thank you Compliance-oriented development of innovative medical devices from research to market Workshop at BRI Pontedera, Italy Ovesco Endoscopy AG Tuebingen, Germany Dr. Sebastian Schostek
GUIDANCE 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.
Safeguarding public health The Regulation of Software as a Medical Device
Safeguarding public health The Regulation of Software as a Medical Device Dr Head of New and Emerging Technologies Medicines and Healthcare Products Regulatory Agency (MHRA) Crown Copyright 2013 About
(OJ L 169, 12.7.1993, p. 1)
1993L0042 EN 11.10.2007 005.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning
CE Marking: Your Key to Entering the European Market
CE Marking: Your Key to Entering the European Market N. Gerard Zapiain U.S. Department of Commerce International Trade Administration Office of Microelectronics, Medical Equipment and Instrumentation I.
Medical 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
Med-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
How 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
2002 No. 618 CONSUMER PROTECTION. The Medical Devices Regulations 2002
STATUTORY INSTRUMENTS 2002 No. 618 CONSUMER PROTECTION The Medical Devices Regulations 2002 Made - - - - - 20th May 2002 Laid before Parliament 21st May 2002 Coming into force - - 13th June 2002 ARRANGEMENT
Medical 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
Reporting 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 &
GUIDANCE 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
WHITEPAPER: 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 [email protected]
Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC
Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC August 2013 Contents 1 Introduction...3 2 Scope of the directive...3 2.1 What is an in vitro diagnostic medical device?... 3 2.2 Specimen
Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994
Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical SUR-G0014-1 12 NOVEMBER 2013 This guide does not purport to be an interpretation of law and/or regulations
An introduction to the regulation of apps and wearables as medical devices
An introduction to the regulation of apps and wearables as medical devices Introduction Phones are increasingly equipped with a range of devices capable of being used as sensors, including gyroscopes,
UNDERSTANDING 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
Regulatory Strategy for Drug-Device Combinations By John Worroll
THE MEDICAL DEVICE CONSULTING, AUDITING & TRAINING EXPERTS Regulatory Strategy for Drug-Device Combinations By John Worroll Introduction Drug-device combinations have always been a challenge to the regulatory
National Decontamination Guidance on Loan Medical Devices (Reusable): Roles & Responsibilities GUID 5002
National Decontamination Guidance on Loan Medical Devices (Reusable): Roles & Responsibilities GUID 5002 July 2015 Contents Page 1.0 Executive summary... 3 2.0 Background... 4 3.0 Objective... 5 4.0 Scope...
Medical 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,
Medical 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
MEDICAL DEVICES INTERIM REGULATION
Issued by the Saudi Food and Drug Authority Board of Directors decree number 1-8-1429 and dated 27 December 2008 The Interim was published in Umm Al-QURA Journal year 86 Issue No:4249 dated in 17 April
Medical 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
Navigating the New EU Rules for Medical Device Software
Navigating the New EU Rules for Medical Device Software Mathias Klümper and Erik Vollebregt examine how European Directive 2007/47/EC will affect requirements for medical device software. Directive 2007/47/EC
CE Marking Changing & Evolving Requirements September 2013 2013 BSI Healthcare Roadshow
CE Marking Changing & Evolving Requirements September 2013 2013 BSI Healthcare Roadshow Existing Directives 2 Directive 93/42/EEC 1. Check Scope of Medical Device Directive (Article 1) 2. Determine Device
Basic Information about the European Directive 93/42/EEC on Medical Devices
Basic Information about the European Directive 93/42/EEC on Medical Devices mdc medical device certification GmbH Kriegerstraße 6 D-70191 Stuttgart, Germany Phone: +49-(0)711-253597-0 Fax: +49-(0)711-253597-10
Guidelines for conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products
EUROPEAN COMMISSION DG HEALTH & CONSUMERS Directorate B - Consumer Affairs Unit B2 Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDDEV 2.2/4 January 2012 Guidelines for conformity
US & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR
US & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR A MEDICAL DEVICE IS A MEDICAL DEVICE IS A MEDICAL DEVICE AHWP Medical SW Workshop Taipei, Taiwan November 3, 2012 John G. Abbott,
Schneps, Leila; Colmez, Coralie. Math on Trial : How Numbers Get Used and Abused in the Courtroom. New York, NY, USA: Basic Books, 2013. p i.
New York, NY, USA: Basic Books, 2013. p i. http://site.ebrary.com/lib/mcgill/doc?id=10665296&ppg=2 New York, NY, USA: Basic Books, 2013. p ii. http://site.ebrary.com/lib/mcgill/doc?id=10665296&ppg=3 New
Final Document. Software as a Medical Device (SaMD): Key Definitions. Date: 9 December 2013. Despina Spanou, IMDRF Chair. IMDRF/SaMD WG/N10FINAL:2013
Final Document Title: Authoring Group: Software as a Medical Device (SaMD): Key Definitions IMDRF SaMD Working Group Date: 9 December 2013 Despina Spanou, IMDRF Chair This document was produced by the
Emerging Device Topics for Regulatory Consideration.. Janine Jamieson May 2015
Emerging Device Topics for Regulatory Consideration. Janine Jamieson May 2015 Disclaimer These are my personal views and not necessarily those of MHRA as an organisation. 2 European regulation of combination
Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device
Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device List of Contents Page 1. Introduction 1.1 The Medical Device Administrative Control System and the 3 proposed legislation
Medical Certification: Bringing genomic microcores to clinical use OI- VF- WP- 011
Medical Certification: Bringing genomic microcores to clinical use VoltedFlow GmbH Industriestrasse 23, 6055, Alpnach Dorf, Switzerland 1 Summary VoltedFlow has developed solutions to vastly speed up DNA
The Act on Medical Devices
The Act on Medical Devices The Act on Medical Devices of 2 nd August 1994 (Federal Law Gazette I, p. 1963), in the version of 7 th August 2002 (Federal Law Gazette I, p. 3146), last amended by Article
Guidance 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
Introduction Processes and KPIs Health Care Value Chain. Rafael Provencio
Introduction Processes and KPIs Health Care Value Chain Rafael Provencio Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 2 What is the goal of the regulatory framework?
Clinical 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.
GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
MEDICAL DEVICE CONTROL DIVISION Ministry of Health, Malaysia Regulatory Requirements for Medical Device Safety & Performance GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD) DRAFT DRAFT 1 September
Medical Device Software Standards for Safety and Regulatory Compliance
Medical Device Software Standards for Safety and Regulatory Compliance Sherman Eagles +1 612-865-0107 [email protected] www.softwarecpr.com Assuring safe software SAFE All hazards have been addressed
NOTICE TO MANUFACTURERS OF RADIOTHERAPY MEDICAL DEVICES
French health products safety agency Medical Devices Evaluation Directorate Market Surveillance Department Matter handled by Pascal Di Donato Email: [email protected] August 2007 NOTICE
BSI 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 [email protected] bsigroup.com
Medical Devices. IRELAND Arthur Cox
Medical Devices IRELAND Arthur Cox CONTACT INFORMATION Colin Kavanagh Arthur Cox Earlsfort Centre Earlsfort Terrace Dublin 2, Ireland +353.1.618.0548 [email protected] www.arthurcox.com 1. Definition
Software within the medical device regulatory framework in the EU
Software within the medical device regulatory framework in the EU E-HEALTH WEEK (AMSTERDAM, 10 JUNE 2016) Erik Hansson, Deputy Head of Unit, DG GROWTH - Health Technology and Cosmetics, European Commission
Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes.
Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes.. www.pharmout.net Page 1 of 15 Version-02 1. Scope 1.1. Purpose This paper reviews the implementation of the ANSI/AAMI/IEC
Processes for the Development of Healthcare Applications. Christian Johner
Processes for the Development of Healthcare Applications Christian Johner Process/Life-Cycle Models: The true history Directives and Standards: Requirements with Respect to Processes Conclusion, Recommendations
GUIDELINES ON MEDICAL DEVICES. IVD GUIDANCES : Borderline issues 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. 2.14/1 rev. 1 January
CHAPTER 3 SCOPE AND STANDARDS OF NURSING PRACTICE AND CNA ROLE
CHAPTER 3 SCOPE AND STANDARDS OF NURSING PRACTICE AND CNA ROLE Section 1. Statement of Purpose. These Board Rules are adopted to implement the Board's authority to regulate the scope and practice of nursing
GUIDELINES 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
Registration of Class B Medical Devices
Registration of Class B Medical Devices 1 INTRODUCTION Medical devices are classified based on a rule based risk classification system into four risk classes Class A to D with Class A being the lowest
Quality Assurance Manual
Quality Assurance Manual Revised April 30, 2014 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014 Fluke Corporation, All rights reserved. Printed in U.S.A. All product names are trademarks
EU Law and Life Sciences Mobile Health Apps. Webinar - Brussels, 9 July 2014
EU Law and Life Sciences Mobile Health Apps Webinar - Brussels, 9 July 2014 Dr. Dr. Adem Koyuncu, M.D. Partner Prof. Damien Geradin Partner Agenda Covington at a glance Mobile health apps - opportunities
GUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Health technology and Cosmetics MEDDEV 2.12/2 rev2 January 2012 GUIDELINES ON MEDICAL DEVICES POST MARKET CLINICAL FOLLOW-UP
MONTANA STATE HOSPITAL POLICY AND PROCEDURE WORKER S COMPENSATION
MONTANA STATE HOSPITAL POLICY AND PROCEDURE WORKER S COMPENSATION Effective Date: May 14, 2015 Policy #: SF-07 Page 1 of 4 I. PURPOSE: A. To identify responsibilities in the event of a work related injury
EPF Position Statement on the European Commission s proposal for a Regulation on In Vitro Medical Devices
EPF Position Statement on the European Commission s proposal for a Regulation on In Vitro Medical 03/09/2013 In Vitro Diagnostic medical devices include all tests performed to provide a diagnosis by assessing
Glossary of terms used in our standards. June 2010. Upholding standards and public trust in pharmacy www.pharmacyregulation.org
Glossary of terms used in our standards June 2010 About us The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians and registered pharmacy premises in England, Scotland
This is Document Schedule 5 Part 1 referred to in this Contract SCOTTISH MINISTERS REQUIREMENTS SCHEDULE 5 PART 1 QUALITY MANAGEMENT SYSTEM
This is Document Schedule 5 Part 1 referred to in this Contract SCOTTISH MINISTERS REQUIREMENTS SCHEDULE 5 PART 1 QUALITY MANAGEMENT SYSTEM CONTENTS Page No 1 GENERAL REQUIREMENTS 1 1.1 Requirements 1
Vigilance 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
Medical Device Classification
Medical Device Classification Dan O Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC [email protected] www.ombuenterprises.com 603-209-0600 1 Speaker Biography Dan O Leary Dan
Conformity assessment certification
TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA
CE 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
AGREEMENT On the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union
AGREEMENT On the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union The Member States of the Eurasian Economic Union, hereinafter referred to
A Revised EMC Directive from Europe
TÜV America Inc. Phone: (978) 739-7000 5 Cherry Hill Drive Fax: (978) 777-8441 Danvers, MA 01923 E-mail: [email protected] www.tuvamerica.com A Revised EMC Directive from Europe INTRODUCTION The Commission
The 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
Risk Management and the Impact of EN ISO 14971:2012 Annex Z
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 Risk
APMI CODE OF PRACTICE ON ADVERTISING OF MEDICINAL PRODUCTS ISSUE 1
APMI CODE OF PRACTICE ON ADVERTISING OF MEDICINAL PRODUCTS ISSUE 1 August 2010 1. Introduction... 2 2. Scope... 3 3. Definitions... 4 4. General rules of advertising of medicinal products... 6 5. Advertising
EMKI has competence in conformity assessment - on the basis of EU directives 93 /42/EEC - for companies dealing with product ranges listed below.
EMKI COMPETENCE in MD EMKI has competence in conformity assessment - on the basis of EU directives 93 /42/EEC - for companies dealing with product ranges listed below. Annex II.: EC DECLARATION OF CONFORMITY
The Regulation of Medical Devices in the UK
The Regulation of Medical Devices in the UK 1. What are the main requirements for a medical device to enter into the market and how are they regulated? Are there any licensing, marketing authorisation,
Manual 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.
The Medical Products Agency s Working Group on Medical Information Systems. Project summary
The Medical Products Agency s Working Group on Medical Information Systems Project summary Proposal for guidelines regarding classification of software based information systems used in health care This
Konformitätsbewertung 3.9 B 17. Guidance for Notified Bodies auditing suppliers to medical device manufacturers
Antworten und Beschlüsse des EK-Med Konformitätsbewertung 3.9 B 17 Guidance for Notified Bodies auditing suppliers to medical device manufacturers Herkunft Notified Body Operations Group Quellen NBOG BPG
Introduction 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
International standards and guidance that address Medical Device Software
International standards and guidance that address Medical Device Software Sherman Eagles Technical Fellow Medtronic CRDM Convener IEC 62A/ISO 210 JWG3 Co-convener IEC 62A/ISO 215 JWG7 Standards in the
WORKING DOCUMENT FOR SCC CONSULTATION CONSTRUCT09/874 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
WORKING DOCUMENT FOR SCC CONSULTATION CONSTRUCT09/874 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL New Approach Industries, Tourism and CSR Construction, Pressure Equipment, Metrology
Regulatory Considerations for Medical Device Software. Medical Device Software
Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Kenneth L. Block, RAC October 7, 2015 Galway, Ireland Offices: Dallas, Texas (12 employees) Tokyo, Japan
PLM: Privat Label Manufacturer (Customer of the OEM-PLM relation) OEM: Original Equipment Manufacturer (Supplier of the OEM-PLM relation)
1 Area of application of the product documentation in case of a Privat Label Manufacuter according to OEM procedure. To apply with new certification applications and sample evas in the context of the regular
GOVERNMENT OF THE RUSSIAN FEDERATION RESOLUTION from December 27, 2012 N 1416 APPROVAL OF THE RULES STATE REGISTRATION OF MEDICAL PRODUCTS
GOVERNMENT OF THE RUSSIAN FEDERATION RESOLUTION from December 27, 2012 N 1416 APPROVAL OF THE RULES STATE REGISTRATION OF MEDICAL PRODUCTS In accordance with Article 38 of the Federal Law "On the basis
Health Informatics Application of clinical risk management to the manufacture of health software Formerly ISO/TS 29321:2008(E) DSCN14/2009
Health Informatics Application of clinical risk management to the manufacture of health software (formerly ISO/TS 29321:2008(E)) DSCN14/2009 Programme Sub-Prog / Project NPFIT Clinical Safety Document
CE MARKING OF MEDICAL DEVICES Guide
CE MARKING OF MEDICAL DEVICES Guide Edition 2005 CE marking of medical devices Instructions for use LNE / G-MED 1/63 CONTENTS 1. Introduction to the guide 2. Regulation 2.1. European directives regarding
Correspondence between ISO 13485:2003 and the US Quality System Regulation
Correspondence between ISO 13485:2003 and the US Quality System Regulation Correspondence between ISO 13485:2003 and the US Quality System Regulation 1 Scope 1.1 General This International Standard specifies
BSI: An In Vitro Diagnostics Notified Body. A guide to the In Vitro Diagnostic Directive....making excellence a habit.
BSI: An In Vitro Diagnostics Notified Body A guide to the In Vitro Diagnostic Directive...making excellence a habit. A BSI guide to the In Vitro Diagnostic Directive Introduction In Vitro Diagnostics (IVD)
Regulated Mobile Applications
Regulated Mobile Applications Sion Wyn Conformity +[44] (0) 1492 642622 [email protected] Waters, Wilmslow, November 2014 1 Introduction According to industry estimates, 500 million smartphone users
Medical Device Regulatory Requirements for Taiwan
Medical Device Regulatory Requirements for Taiwan Disclaimer: The information contained on this website is derived from public sources and is current to the best of the knowledge of the Department of Commerce
MEDICAL DEVICES REGULATIONS
MEDICAL DEVICES [S.L.427.44 1 SUBSIDIARY LEGISLATION 427.44 MEDICAL DEVICES REGULATIONS 21st March, 2010 LEGAL NOTICE 210 of 2008. 1. (1) The title of these regulations is the Medical Devices Regulations.
A. CPT Coding System B. CPT Categories, Subcategories, and Headings
OST 148 MEDICAL CODING, BILLING AND INSURANCE COURSE DESCRIPTION: Prerequisites: None Corequisites: None This course introduces CPT and ICD coding as they apply to medical insurance and billing. Emphasis
Medical Information Systems. guidance for qualification and classification of standalone software with a medical purpose
approvals authorisation clinical trials communication competence cosmetics dialogue directives efficacy environment evaluation guidelines harmonisation health economics herbals homeopathics information
Clinical Data for Medical Devices
White Paper Clinical Data for Medical Devices Preparing for increased requirements in the EU Table of Contents 1. Regulation of medical devices in the EU: on the cusp of change... 3 2. Traditional differences
Medical Device Training Program 2015
Medical Device Training Introduction Supplementary training and education is often overlooked by medical device professionals until it is triggered by an upcoming FDA or Notified Body and/or ISO 13485
SECTION 1: REQUIREMENTS FOR CERTIFICATES OF COMPLIANCE FOR CLASSES OF RADIATION APPARATUS
Department of Health and Human Services Population Health Radiation Protection Act 2005 Section 17 CERTIFICATE OF COMPLIANCE: STANDARD FOR RADIATION APPARATUS - X-RAY MEDICAL DIAGNOSTIC (BIOPSY) SECTION
Understanding Medical Device Regulation for mhealth A Guide for Mobile Operators
for mhealth A Guide for Mobile Operators 1 Foreword Mobile technologies will make a significant contribution to addressing the enormous challenges of healthcare provision worldwide. Early efforts in mobile
Response of the German Medical Association
Response of the German Medical Association to the European Commission proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and
How To Protect Mental Health Information In Upb
UNIVERSITY PHYSICIANS OF BROOKLYN, INC. POLICY AND PROCEDURE Subject: MENTAL HEALTH INFORMATION Page 1 of 6 No: Prepared by: Shoshana Milstein Original Issue Date: NEW Reviewed by: HIPAA Policy & Procedure
Revision of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices. Response from Cancer Research UK to the Commission August 2010
Revision of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices Response from Cancer Research UK to the Commission August 2010 1. Cancer Research UK (CR-UK) 1 is leading the world in finding
Abstract. Introduction
Map that App event hosted by Oxford AHSN 29 th January 2014 Healthcare smartphone app development Prepared by: Emma Roberts 7 th January 2014 Abstract This report aims to highlight some of the key issues
Frequently Asked Questions. Unannounced audits for manufacturers of CE-marked medical devices. 720 DM 0701-53a Rev 1 2014/10/02
Frequently Asked Questions Unannounced audits for manufacturers of CE-marked medical devices 720 DM 0701-53a Rev 1 2014/10/02 What is an unannounced audit?... 6 Are unannounced audits part of a new requirement?...
Medical Technologies Evaluation Programme Methods guide
Issue date: April 2011 Medical Technologies Evaluation Programme Methods guide National Institute for Health and Clinical Excellence MidCity Place 71 High Holborn London WC1V 6NA www.nice.org.uk National