Medical Device Training Program 2015

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1 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 certification audit. The requirement for training is, nevertheless, an essential element of all Quality Management Systems, and should not be confined to only those occasions. The Qserve is able to offer training which is tailored to meet your needs. This can vary from a day training course on specialist subjects to multiple-day courses, specifically targeted at management or production staff, as required. These courses also offer an opportunity to meet fellow professionals and to exchange valuable information. They are conducted in small groups with a specified maximum number of participants. Qserve delivers courses and training in English, German, France and in Dutch, at Qserve offices, external locations and on-site at your own organization both in the EU and the US. These can be concluded, if required, with an examination and/or certificate. Our expert trainers all have many years of real experience in their own particular areas of the Medical Device Industry, ensuring your company a high quality training session. The Qserve offers a wide range of training courses which encompass every aspect of Quality Management and Regulatory Affairs and emphasize the Practical Approach for more than 15 years. In the following table you ll find our standard training overview.please be advised that extensions of the individual training programs over multiple days are always possible to cover additional and specific requirements of the customer or additional and specific country/region requirements. All trainings can be tailored to satisfy your specific needs and expectations, including the use of your own Quality Management System, your own product Technical Documentation and your own product range for inclusion in the cases and exercises. Any combination of trainings can be chosen to provide for an efficient and effective training planning. We are able to provide all these trainings at your location worldwide, from our office in The Netherlands or in the USA and will support you in providing the training efficiently, to minimize travel and lodging expenses. The Qserve Team

2 Overview of all training subjects 2015 Title (days) Page Introduction to ISO a Global overview Comprehensive study of ISO and relation with ISO Internal auditor ISO A Practical Guide 2 6 Internal auditor FDA 21 CFR 820 Quality System Regulations - A Practical Guide 2 7 Internal auditor ISO & 21 CFR 820 Quality System Regulations - A Practical Guide 2 8 Supplier auditing Instrument to control your suppliers and subcontractors 1 9 Risk management for Medical Devices ISO using FMEA 1 10 Introduction to the European Medical Device Directives - a better understanding 1 11 Medical Device Regulations in the European Union: CE marking in detail 2 12 Medical Device Classification & Conformity Assessment Routes with a focus on Europe, Australia, USA and Canada Post Market Surveillance & Vigilance with a focus on Europe, USA, Canada, Australia and Japan How to construct a Technical File for Worldwide use - STED model of the GHTF 1 15 Pre-clinical testing, Clinical (Study) evaluation using ISO & MEDDEV Introduction to Biocompatibility ISO series - a better understanding 1 17 Medical Devices Process validation - IQ/OQ/PQ 1 18 Introduction to FDA 21 CFR 820 Quality System Regulations 1 19 Introduction to FDA 21 CFR 11: Electronic Records; Electronic Signatures 1 20 FDA s 510(k) & PMA submissions - explained in detail 2 21 FDA s Pre-Ide process - explained in detail 1 22 Introduction to SOR/ Canadian Medical Device Regulations - a better understanding 1 23 Design control for a Medical Device Manufacturer A comprehensive model 2 24 Page 2

3 Title (days) Page Electrical basic safety according to IEC rd edition explained in detail 1 25 Radiation (Incl. EMC) basic safety according to IEC rd edition and IEC explained in detail 1 26 Mechanical- and basic safety according to IEC rd edition explained in detail 1 27 Software requirements according to IEC clause 14 3rd edition and IEC explained in detail 1 28 Page 3

4 Introduction to ISO A Global overview The one day course Introduction to ISO 13485, Medical Devices - Quality Management Systems -Requirements for Regulatory Purposes, provides an insight in the use of the Standard as basis for a Quality Management System for Medical Device manufacturers. During the course requirements of ISO are reviewed and comparisons to business processes are made. Participants will gain an awareness of the contents and context of the Standard. On completion of the training, participants will Understand the scope and use of ISO as basis of Medical Device Regulations Worldwide Interpret the clauses of ISO Recognize the role and responsibilities of management Environment of ISO in the Medical Device Industry Introduction of ISO and comparison with ISO 9001 Process approach Documentation of a Quality Management System Responsibilities of Management Management of resources Product realization Measurement, Analysis and Improvement Senior Management Quality Managers Regulatory Affairs Managers Internal and external Auditors Anyone involved with the implementation of the Standard ISO There is no prerequisite for this course knowledge of the quality management systems, e.g. ISO 9001 or ISO Page 4

5 Comprehensive study of ISO And relation with ISO The two day course Introduction to ISO13485, Medical Devices Quality Management Systems - Requirements for Regulatory Purposes, together with ISO 14971, Medical Devices - Application of Risk Management to medical devices, provides the insight and tooling to set up and maintain a Quality Management System on a risk based approach. Understand the scope and use of ISO as basis of Medical Device Regulations Worldwide Interpret the clauses of ISO in detail Role of and relation with risk management according ISO How to set up, implement and maintain a Quality Management System the gained knowledge. A quiz is used to test the knowledge of ISO at the closing of the course. An examination with multiple choice and open questions can be provided for upon request. Environment of ISO in the Medical Device Industry Introduction of ISO and comparison with ISO 9001 Process approach Documentation of a Quality Management System Product realization Management of resources Risk management Evening program: case on risk analysis Documentation of a Quality Management System Responsibilities of Management Measurement, Analysis and Improvement Senior Management Quality Managers and Regulatory Affairs Managers Internal and external Auditors Anyone involved with the implementation of the Standard ISO There is no prerequisite for this course knowledge of the quality management systems, ISO 9001 or ISO days, including refreshments, lunches, diner and overnight stay. Page 5

6 Internal auditor ISO A Practical Guide An effective internal audit system is a powerful management tool to monitor compliance to the Standard and implement improvement. Auditor skills and behaviour for an effective auditor are discussed and exercised. Understand the scope and use of ISO as basis for internal auditing Interpret the clauses of ISO in detail from an internal auditors perspective Understand and explain the basics of auditing Different types of auditing Use the techniques for interviewing and assessing processes Prepare and perform an internal audit Communicate the results to the auditee and report the results of an internal audit During the course cases and exercises are used to verify the gained knowledge and skills. It is also possible to combine the exercises in your own internal audit program. Environment of ISO in the Medical Device Industry Introduction of ISO and comparison with ISO 9001 Process approach Comprehensive contents of ISO (including focus of internal auditor) Internal audit process Define an audit program Auditor skills and behaviour Preparing, performing and reporting an audit Auditing in practice Internal and external Auditors Quality Managers and Regulatory Affairs Managers nine to provide a stimulating and practical There is no prerequisite for this course knowledge of the quality management systems, ISO 9001, ISO or 21 CFR 820 QSR. 2 days, including refreshments, lunches, diner and overnight stay. Page 6

7 Internal auditor FDA 21 CFR 820 Quality System Regulations - A Practical Guide An effective internal audit system is a powerful management tool to monitor compliance to the Standard and Regulations and implement improvement. Auditor skills and behaviour for an effective auditor are discussed and exercised. Understand the scope and use of FDA QSR as basis for internal auditing Interpret the clauses of FDA QSR in detail from an internal auditors perspective Understand and explain the basics of auditing Different types of auditing Use the techniques for interviewing and assessing processes The QSIT approach Prepare and perform an internal audit Communicate the results to the auditee and report the results of an internal audit the gained knowledge and skills. It is also possible to combine the exercises in your own internal audit program. Environment of FDA QSR in the Medical Device Industry Introduction of FDA QSR comparing and contrasting Process approach Comprehensive contents FDA QSR (including focus of internal auditor) Internal audit process Define an audit program Auditor skills and behaviour The QSIT approach Preparing, performing and reporting an audit Auditing in practice Internal and external Auditors Quality Managers and Regulatory Affairs Managers nine to provide a stimulating and practical There is no prerequisite for this course knowledge of the 21 CFR 820 Quality System Regulations 2 days, including refreshments, lunches, diner and overnight stay. Page 7

8 Internal auditor ISO & 21 CFR 820 Quality System Regulations - A Practical Guide An effective internal audit system is a powerful management tool to monitor compliance to the Standard and Regulations and implement improvement. Auditor skills and behaviour for an effective auditor are discussed and exercised. Understand the scope and use of ISO and FDA QSR as basis for internal auditing Interpret the clauses of ISO and FDA QSR in detail from an internal auditors perspective Understand and explain the basics of auditing Different types of auditing Use the techniques for interviewing and assessing processes The QSIT approach Prepare and perform an internal audit Communicate the results to the auditee and report the results of an internal audit the gained knowledge and skills. It is also possible to combine the exercises in your own internal audit program. Environment of ISO and FDA QSR in the Medical Device Industry Introduction of ISO and FDA QSR comparing and contrasting Process approach Comprehensive contents of ISO and FDA QSR (including focus of internal auditor) Internal audit process Define an audit program Auditor skills and behaviour Preparing, performing and reporting an audit Auditing in practice Internal and external Auditors Quality Managers and Regulatory Affairs Managers nine to provide a stimulating and practical There is no prerequisite for this course knowledge of the quality management systems, ISO 9001 or ISO days, including refreshments, lunches, diner and overnight stay. Page 8

9 Supplier auditing - Instrument to control your supplier and subcontractors Relations of customer and suppliers and subcontractors become more complex, more required by Regulatory requirements and worldwide. Assessment of suppliers and subcontractors; the role of a supplier audit is underestimated. A well prepared and structured supplier audit program is a supplier management tool providing additional information besides delivery performance and complaints. Explain the purpose and structure of supplier audits Detect pitfalls and handle non conforming situations Define a supplier audit plan Prepare and perform an effective supplier audit the gained knowledge and skills. Role of supplier auditing in supplier management Supplier auditing compared to internal auditing Customer supplier relations and effect on supplier auditing Supplier auditor skills and behaviour Define an supplier audit program Kick off meeting with Supplier s management Perform a supplier audit Closing meeting and reporting results Senior Management Quality Managers and Regulatory Affairs Managers Supplier Auditors nine to provide a stimulating and practical There is no prerequisite for this course knowledge of ISO and having followed the course on internal auditing. Page 9

10 Risk management for Medical Devices ISO Using FMEA Risks play an important role in the development, production and use of Medical Devices. This course provides insight in the process and importance of Risk Management throughout the whole lifecycle of a medical device. Failure Mode and Effect Analysis is an widely accepted tool and will be introduced, including a exercise. Understand and explain the basic concepts of Risk Management Explain the Risk Management Process in relation to the product Lifecycle Understand and use the stages in the Risk Management Process Apply Failure Mode and Effect Analysis on a Medical Device the gained knowledge. Relation of Risk Management with ISO Concepts and definitions of Risk Management Stages of the Risk Management process Use of the various annexes of ISO during the stages in the Risk Management process Product Risk Analysis: use of Failure Mode and Effect Analysis Risk Management report Senior Management Quality Managers and Regulatory Affairs Managers Product Developers and Product Managers Members of Risk management teams Anyone involved with the implementation of Medical Devices to the market nine to provide a stimulating and practical There is no prerequisite for this course knowledge of the quality management systems and a basic awareness of Medical Devices. Page 10

11 Introduction to the European Medical Device Directives - A better understanding To provide a basic understanding of the landscape of the Medical Device Regulations in Europe. Participants will gain knowledge of the requirements of the Medical Device Directives and the approach of CE marking. Availability of Guidance documentation is researched. The MDD 93/42/ EC valid per March 21, 2010 is used as basis for this course. Understand the Medical Device Regulations approach in Europe Understand the structure and purpose of the Medical Device Directives Explain the use of Essential Requirements, including the use of standards Identify the conformity assessment routes Understand the importance and role of Risk Management Understand the importance and role of Clinical Data Find Guidance Documentation on the Web Senior Management, Regulatory Affairs Managers and Quality Managers Design, Development, Manufacturing and Marketing Managers Internal and external Auditors The number of participants is maximized to sixteen to provide adequate time for discussion and reflection. There is no prerequisite for this course. Medical Device Directives and the New Approach Legal and operational structure Structure and purpose of MDD 93/42/EC General contents of MDD 93/42/EC Guidance Documentation (MEDDEV, GHFT, NB-MED, etc) Article 11: conformity Assessment routes Annex I: Essential Requirements Annex 10: Clinical Evaluation Page 11

12 Medical Device Regulations in the European Union: CE marking in detail To provide participants with the knowledge to assist their companies in getting products to market more quickly. Management personnel responsible for all aspects of CE marking medical devices will benefit from this course. Participants will gain in-depth knowledge of the requirements of the Medical Device Directive and the CE Marking approach. The Medical Device Directive 93/42/EC will be discussed in detail as model for the other Medical Device Directives. Understand the Medical Device Regulations approach in Europe Understand the structure and purpose of the Medical Device Directives Explain the use of Essential requirements, including the use of (harmonized) Standards Apply the Classification Criteria and Implementation rules) Identify the conformity assessment routes Identify Technical Documentation requirements Importance and Role of Clinical Data Identify the importance and contents of Post Market Surveillance Medical Device Directives and the New Approach Legal and operational structure Structure and purpose of MDD 93/42/EC General contents of MDD 93/42/EC Guidance Documentation (MEDDEV, GHFT, NB-MED, etc) Article 11: conformity Assessment routes (including Annex II to Annex VII) Annex I: Essential Requirements Role and importance of Risk Management Post Market Surveillance Vigilance and reporting to the Competent Authority Annex 10: Clinical Evaluation Senior Management, Regulatory Affairs Managers and Quality Managers Design, Development, Manufacturing and Marketing Managers Internal and external Auditors There is no prerequisite for this course knowledge of the Medical Device Regulations in Europe. 2 days, including refreshments, lunch diner and overnight stay. Page 12

13 Medical Device Classification & Conformity Assessment Routes - With a focus on Europe, Australia, USA and Canada Medical devices are regulated differently in Europe, Australia, USA and Canada. This course explains the differences and similarities between the Medical Device Regulations and how to benefit from a simultaneous approach. Understand the differences and similarities between the Medical Device Regulations in Europe, Australia, USA and Canada Understand and apply the different Classifications rules Understand the different Conformity Assessment Routes Medical Device Regulations in Europe, Australia, USA and Canada; similarities and differences Medical Device Classification & Conformity Assessment Routes in Europe Mutual recognition of CE marking in Australia Medical Device Classification & Conformity Assessment Routes in Canada Medical Device Classification & Conformity Assessment Routes in the USA How to benefit from simultaneous submissions Senior Management Quality Managers Regulatory Affairs Managers Internal and external Auditors Anyone involved with the implementation of the Medical Device Directives There is no prerequisite from this course knowledge of the various Medical Device Regulations. Page 13

14 Post Market Surveillance & Vigilance with a focus on Europe, USA, Canada, Australia and Japan Proactive and reactive sources are a requirement of all Medical Device Regulations worldwide. This course helps you in defining and understanding the requirements and use of applicable Guidance documentation and provides your organisation with an early warning system for continuous compliance with Regulations. Understand the similarities and differences of PMS requirements in the various Regulatory regions Understand the similarities and differences of Vigilance requirements in the various Regulatory regions Define both a PMS and Vigilance workflow combining all sources of information Concepts of an early warning system worldwide Post Market Surveillance requirements: similarities and differences Compose sources of information into a PMS plan Include Post Market Clinical Follow up into a PMS plan PMS results: what to do with them? Vigilance requirements: similarities and differences Recognise a complaint to be handled as an incident Set up and workflow of a Vigilance SOP Regulatory professionals Quality Managers Clinical Affairs specialists Design and Development specialists Those who are involved in Sales and Marketing Participants will benefit from a basic knowledge of quality management systems and medical device regulations. Page 14

15 How to construct a Technical File for Worldwide use - STED model of the GHTF Introduction of a Medical Device onto the market always incorporates the completion of Technical Documentation for demonstrating conformance to applicable Medical Device Regulations. The GHTF has developed a Summary Technical Documentation (STED) which provides benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices. it enables a manufacturer to prepare a STED and provide different Regulatory Authorities or Conformity Assessment Bodies with the same body of documentary evidence. Define the Regulatory requirements for Technical Documentation Structure the documentary evidence according the STED Guidance Define key subjects as part of the Technical Documentation Prevent serious shortcomings in parts of the Technical Documentation of a Medical Device Environment of Medical Device Regulations Documentary Evidence Requirements Purpose and structure of the GHTF model: Summary Technical Documentation Key subjects in the STED How to use STED with medical device groups Control of Technical Documentation Keeping the Technical Documentation up to date Quality Managers Regulatory Affairs Managers Design and Development specialists Anyone involved with product development, including Sales and Marketing nine to provide a stimulating and practical There is no prerequisite from this course knowledge of various Medical Device Regulations. Page 15

16 Pre-clinical testing, Clinical (Study) evaluation - Using ISO & MEDDEV The objective of this course is to provide an overview of the preparation, design and management aspects of clinical trials for medical devices. Upon completion of this course, attendees will have an understanding of the unique challenges faced in clinical trials for medical devices, which will be useful in the future development of device technology. Understand and explain the requirements on Clinical Evaluation Outline a clinical strategy Plan and document the results of a Literature Investigation Understand the requirements for a Clinical Trail Define procedures on Clinical Evaluation in a Quality Management System Understand the rules and approach for Post Market Clinical Follow up Clinical evaluation an Introduction ISO the standard explained Use of the MEDDEV 2.7 Guidelines on Medical Devices: Clinical Evaluation Clinical Strategy outline Writing a clinical evaluation report Literature route Introduction of management of Clinical trials Preparation and design of Clinical trials Integration of the procedures on Clinical Evaluation in your QMS Post Market Clinical Follow up Clinical Specialists Product development Managers and team members Product Managers Quality Managers and Regulatory Affairs Managers Anyone involved in the Clinical Evaluation of Medical Devices nine to provide a stimulating and practical There is no prerequisite from this course knowledge of ISO and Medical Device Regulations. Page 16

17 Introduction to Biocompatibility evaluation - a better understanding Evaluation of biological safety issues is necessary to demonstrate safety of your medical devices when it comes into contact with the human body. Safety issues during development, production and use of the medical are to be detected and managed. It is explained how biocompatibility evaluation can be handled in an effective and efficient way. Understand the applicable requirements of the Medical Device Regulations Decide when evaluation and testing of biological reactions is applicable Define how to evaluate biological safety issues as part of Risk management How to use the ISO series and other relevant information Introduction ISO series the approach explained ISO part 1 the Standard explained Biocompatibility evaluation Integrated in the Design and development process When to start biocompatibility evaluation and how to manage the testing Biological safety strategy Challenges, roles and responsibilities of sponsors and investigators Product development Managers and team members Product Managers Quality Managers and Regulatory Affairs Managers Anyone involved in the design and development of Medical Devices There is no prerequisite from this course. Page 17

18 Medical Devices Process validation - IQ/OQ/PQ Process Validation is described as establishing that a process consistently produces a result or product, meeting its predetermined requirements. But how to achieve that? The concepts and use of Installation Qualification and Performance Qualification are discussed and clarified. Understand and explain the concepts and value of process validation Understand and use the concepts of IQ/ OQ/PQ Define and make a Validation Master plan Process validation introduction with a focus medical device requirements Which processes are to be validated? Concepts of IQ / OQ / PQ Installation Qualification in detail Operational Qualification in detail Performance Qualification in detail Prospective versus retrospective validation Validation Master plan When is re-validation needed? Product development Managers and team members Product Managers Quality Managers and Regulatory Affairs Managers Anyone involved in the design and development of Medical Devices There is no prerequisite from this course knowledge of the quality management systems according ISO Page 18

19 Introduction to FDA 21 CFR 820 Quality System Regulations The one day course Introduction to the FDA Quality System Regulations for Medical Devices, provides an overview of the purpose of the regulations and how to build and implement a quality system that meets and exceeds the requirements of the regulation. The goal is to build a quality system that becomes a business system that provides value beyond compliance with basic regulations. Participants will gain an understanding of the value of a quality system as a key element of a successful business model. Understand the scope and use of 21 CFRR 820 as basis of Medical Device Regulations Worldwide Recognize the role and responsibilities of management, R&D, operations, and sales and support elements in an effective and well-run quality system Authority and scope of the FDA Introduction to 21 CR 820 QSIT approach Documentation of a Quality Management System Responsibilities of Management Management of resources Product realization Measurement, Analysis and Improvement Senior Management Quality Managers Regulatory Affairs Managers Internal and external Auditors Anyone involved with the implementation of a quality system There is no prerequisite for this course knowledge of quality management systems, e.g. ISO 9001 or ISO Page 19

20 Introduction to FDA 21 CFR 11: Electronic Records; Electronic Signatures More and more companies are choosing to go to paperless systems for recording and preserving critical quality documents. However, many are unaware that FDA has specific requirements for electronic records and signatures. The one day course Introduction to the FDA 21 CFR 11: Electronic Records; Electronic Signatures, provides an overview of the purpose of the regulations and how to establish and implement an electronic record system that meets the requirements of the regulations. Using real world examples, the goal is to explain in layman s terms the meaning of this very specific set of regulations to enable participants to better ensure that new or existing electronic record systems meet the FDA requirements. Understand the scope and meaning of 21 CFR 11 as a requirement for electronic records and signatures Recognize the role and responsibilities of management, R&D, operations, and sales and support elements in an effective and well-run 21 CFR 11 compliant system Introduction to 21 CR 11 Explanation of Key Terms Closed Systems vs. Open Systems Documentation of the System Security of Data Auditability and Traceability Record Retention, Copies of Records Validation FDA Notification Integrating 21 CFR 11 into an overall 21 CFR 11 / ISO system Senior Management Quality Managers Regulatory Affairs Managers IT Personnel responsible for Quality and Operations computer systems Internal and external Auditors Anyone involved with the implementation of a quality system There is no prerequisite for this course knowledge of computer systems and quality management systems, e.g. 21 CFR 820, ISO 9001 or ISO Page 20

21 FDA s 510(k) & PMA submissions - Explained in detail To provide participants with the knowledge to assist their companies in 1) understanding the US FDA medical device regulatory approval process, 2) developing a regulatory strategy, 3) preparing a submission to FDA. Understand the US FDA device classification process Understand the US FDA submission and approval process Understand how FDA uses Guidance Documents and Recognized Consensus Standards Determine a device classification Identify Submission documentation requirements The evolving role of Clinical Data Current status of changes to the 510(k) process US Food Drug and Cosmetic Act Device classifications The difference between a 510(k) and a PMA Using FDA Guidance Documents Role and importance of Risk Management Senior Management, Regulatory Affairs Managers and Quality Managers Design, Development, Manufacturing and Marketing Managers There is no prerequisite for this course knowledge of the Medical Device Regulations in the US. 2 days, including refreshments, lunch diner and overnight stay. Page 21

22 FDA s Pre-IDE process - Explained in detail This course is intended to provide and overview of the FDA pre-ide process and how it can be used by medical device manufacturers to speed up the submission and approval process. Understand the purpose and intent of the pre-ide process Prepare and submit a pre-ide package Attend a face-to-face pre-ide meeting with US FDA Follow-up with action items to the regulatory pathway following feedback from FDA Overview of the pre-ide process, why is it there, what is its purpose The different stages of pre-ide Format of a pre-ide package, what FDA expects to see What questions to ask in a submssion Summarizing a clinical protocol How to meet with FDA, who should attend, what to say, what not to say Follow-up what to do next Senior Management Regulatory Affairs Managers Clinical Managers There is no prerequisite from this course knowledge of FDA Regulatory processes. Page 22

23 Introduction to SOR/ Canadian Medical Device Regulations - A better understanding To provide a basic understanding of the landscape of the Medical Device Regulations in Canada. Participants will gain knowledge of the requirements of the Canadian Medical Device Regulations (CMDR) and the approach of Health Canada to the Canadian Medical Devices Conformity Assessment System (CMDCAS). The current version of the SOR/ CMDR is used as basis for this course. Explain the Canadian Medical Device Regulations and Medical Devices Conformity Assessment System Role of Health Canada Understand the contents and application of the Canadian Medical Device Regulations Classify Medical Devices according Canadian Medical Device Regulations Understand and apply Medical Device submissions to Health Canada Understand the notification of changes and Mandatory Problem reporting Canadian Medical Devices Conformity Assessment System an introduction Application of the Medical Device Regulations Medical Device Regulations explained in detail Classification of Medical Devices, including similarities and differences with European MD Regulations Establishment Licensing Medical Device Licensing Notification of changes Mandatory problem reporting Senior Management Quality Managers and Regulatory Affairs Managers Internal and external Auditors Anyone involved with the implementation of the Canadian Medical Devices Regulations There is no prerequisite from this course. Page 23

24 Design control for a Medical Device Manufacturer - A comprehensive model You are involved in the product development process for medical devices and have to implement the requirements of ISO Does the Quality Management System support your organisation in designing a safe and functional medical device? Does your product development process lead to the Design and Technical Documentation to support your compliance claim with Medical Device Regulations? Answers will be provided. Determine the requirements of ISO for the product development process Divide the product development process in particle phases, including phase reviews Tune input- and output requirements Determine requirements for verification and validation Determine the required Design and Technical Documentation Medical Device Regulations Role of Essential Requirements for Design Control Design & development requirements of ISO Design File and Technical Documentation for assuring compliance to Regulatory Requirements Design planning, Design Controls and Phases Traceability of requirements Verification and Validation Clinical evaluation Control of Design changes, including Notification to Competent Authorities Product development Managers and team members Product Managers Quality Managers and Regulatory Affairs Managers Anyone involved in the design and development of Medical Devices eight to provide a stimulating and practical There is no prerequisite from this course knowledge of the quality management systems ISO days, including refreshment, lunches, diner and overnight stay. Page 24

25 Electrical basic safety according to IEC rd edition explained in detail To explain in detail the electrical safety and essential performances compliance process. The focus will be on the determination of the applicable product specifications and test requirements. During the course the requirements of the reference IEC and the role of the related particular and collateral standards will be discussed and explained. Participants will gain an awareness of the electrical safety and essential performance compliance process including the extended role of Risk assessment. Understand the electrical safety terms and techniques Understand the requirements of the applicable (collateral) standards for the product development process Understand how to prove the electrical safety of a medical device Understand the requirements for risk assessment and verification and validation Understand the required design and technical documentation the gained knowledge and skills Introduction to medical electrical systems and - equipment classifications Electrical hazards and safety overview and the applicable standards How to proved electrical safety compliance (according to the applicable standards) Determine the essential performance Determine the applicable analyses and tests Cases to perform a risk analysis and electrical safety tests Establish the design and technical documentation records Quality Managers Anyone responsible for the technical design and compliance of medical electrical systems and equipment There is no prerequisite for this course; a basic knowledge of basic safety and essential performance of medical electrical equipment is an advantage Course notes are provided. Page 25

26 Radiation (Incl. EMC) basic safety according to IEC rd edition and IEC explained in detail To provide insight in the Radiation & EMC safety compliance process, explaining the requirements of the IEC and the IEC standards in detail. The characterization of the radiation aspects of the product, risk assessment, and determination of the applicable product specification and test requirements will be discussed. In addition, it will be explained how to set up the final reporting and the Technical Report Forms. Understand the Radiation and EMC safety terms and techniques Understand the requirements of the applicable (collateral) standards for the product development process Understand how to proved the Radiation and EMC safety of a medical device Understand the requirements for risk assessment and verification and validation Understand the required design and technical documentation the gained knowledge and skills Introduction to medical electrical systems and - equipment classifications Radiation and EMC hazards and safety overview and the applicable standards How to proved Radiation and EMC safety compliance (according to the applicable standards) Determine the essential performance Determine the applicable analysis and tests Cases to perform a risk analysis and electrical safety tests Establish the design and technical documentation records Quality Managers Anyone responsible for the technical design and compliance of medical electrical systems and equipment There is no prerequisite for this course; a basic knowledge of basic safety and essential performance of medical electrical equipment is an advantage Course notes are provided. Page 26

27 Mechanical- and basic safety according to IEC rd edition explained in detail During the course the requirements of the reference IEC and related standards are discussed and explained, to provide a detailed understanding of the mechanical and other basic safety compliance processes. Insight will be provided in the mechanical and other basic safety aspects of the production, risk assessment, and the applicable product specification and test requirements. In addition, it will be explained how to set up the final reporting and Technical Report Forms. Understand the mechanical and other basic safety terms and techniques Understand the requirements of the applicable (collateral) standards for the product development process Understand how to proved the mechanical and other basic safety of a medical device Understand the requirements for risk assessment and verification and validation Understand the required design and technical documentation the gained knowledge and skills Introduction to medical electrical systems and - equipment classifications mechanical and other basic hazards and safety overview and the applicable standards How to proved mechanical and other basic safety compliance (according to the applicable standards) Determine the essential performance RoHS and environmental regulations Determine the applicable analysis and tests Cases to perform a risk analysis and mechanical and other basic safety tests Establish the design and technical documentation records Quality Managers Anyone responsible for the technical design and compliance of medical electrical systems and equipment There is no prerequisite for this course; a basic knowledge of basic safety and essential performance of medical electrical equipment is an advantage Course notes are provided. Page 27

28 Software requirements according to IEC clause 14 3rd edition and IEC explained in detail During the course the requirements in the IEC and the IEC will be discussed and explained, to provide a detailed understanding of the software safety compliance process. Insight will be provided in the characterization of the software requirements aspects of the product, risk assessment regard to software verification and validation aspects, determination of the applicable product specification and test requirements. In addition, it will be discussed how to set up the final reporting and Technical Report Forms. Understand the software requirement terms and techniques Understand the requirements of the applicable (collateral) standards for the product development process Understand how to proved the software verification and validation of a medical device Understand the requirements for risk assessment and software safety Understand the required design and technical documentation the gained knowledge and skills Software systems and classifications Software requirements overview and the applicable standards How to proved software verification and validation compliance (according to the applicable standards) Determine the essential performance Data privacy and security Determine the applicable analysis and tests Cases to perform a risk analysis and software safety tests Establish the design and technical documentation records Quality Managers Anyone responsible for the technical design and compliance of medical software systems There is no prerequisite for this course; a basic knowledge of basic safety and essential performance of medical electrical equipment is an advantage Course notes are provided. Page 28

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