Quality and Regulatory Consultancy - E V E N T S 2 0 2 1 · 2021. 6. 4. · Regulatory Affairs EU...

E V E N T S 2 0 2 1Q U N I Q U E G R O U P

A series of Quality Management and Regulatory Affairstrainings provided by QUNIQUE Experts

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Table of Contents Quality Management ISO 13485/MDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING ............................................ 2

ISO 13485/IVDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING ........................................... 3

MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) TRAINING ................................................ 4

INTERNAL AUDITS ACCORDING TO ISO 13485/MDR/ISO 19011 ....................................................... 5

INTERNAL AUDITS ACCORDING TO EU IVDR 2017/746 ..................................................................... 6

Regulatory Affairs EU MDR 2017/745 GENERAL PUBLIC TRAINING ................................................................................. 7

EU IVDR 2017/746 GENERAL PUBLIC TRAINING................................................................................. 9

EU IVDR 2017/746 PERFORMANCE EVALUATION TRAINING ........................................................ 10

EU MDR 2017/745 AND IVDR 2017/746 PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE TRAINING ............................................................................................................................ 11

EU MDR 2017/745 POST-MARKET SURVEILLANCE TRAINING ...................................................... 12

EU IVDR 2017/746 POST-MARKET SURVEILLANCE TRAINING ...................................................... 13

ECONOMIC OPERATORS' OBLIGATIONS TRAINING.......................................................................... 14

ISO 14155:2020 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS UPDATE – BRIDGING THE WAY TO THE EU MDR ...............................................................................15

CLINICAL EVALUATION UNDER THE EU MDR 2017/745 .................................................................. 16

PATHWAY TO THE U.S. MARKET - HOW TO PREPARE A SUCCESSFUL 510(K) FOR YOUR DEVICE ............................................................................................................................................................ 17

EUDAMED ..................................................................................................................................................... 18

INTERNATIONAL REGULATORY AFFAIRS TRAINING FOR MEDICAL REGISTRATIONS .......... 19

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QUNIQUE Quality Management F OC U SE D ON S O L U T I O N S


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ISO 13485/MDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING

Description and benefits: The ISO13485/MDR QMS training will give the attendees an insight into the requirements of the European Union Medical Device Regulation (EU MDR) related to the quality management system as well as an overview of the international standard ISO13485: 2016. A major focus will be on what is new in the ISO 13485:2016 in comparison with the previous version and how EU MDR and ISO 13485:2016 relate to each other. This training gives you an opportunity to fully understand the applicable regulatory requirements as well as gives insight into the concepts introduced by the ISO 13485:2016 in terms of the Quality Management System. Content:

• Opening Remarks • QMS under the EU MDR • Quality Management System • Management Responsibility • Resource Management • Product Realization • Measurement, analysis, and improvement • Relations between MDR and ISO 13485:2016 • Q&A session • Closing remarks

Target group: Quality Managers, Quality Assurance professionals, Quality and Regulatory Affairs professionals, Auditors, Consultants, Medical Device professionals in general Location: Virtual Training Language: English

Price: 699 € Duration: 8 hours

Certification: To be provided in PDF Presentation: To be provided in PDF




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ISO 13485/IVDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING

Description and benefits: The Standard ISO 13485:2016 on Medical devices – Quality management systems – Requirements for regulatory purposes got updated in 2016. The ISO 13485:2016 / EU IVDR QMS training will give the attendees insight into the requirements of the European Union In Vitro Diagnostic Medical Device Regulation (“IVDR”, (EU) 2017/746) related to the quality management system as well as an overview of the international standard ISO 13485:2016. A major focus will be on what is new in both, the IVDR as well as the ISO 13485:2016, and how (EU) IVDR and ISO 13485:2016 relate & complement each other. Through this training, you will gain an understanding of applicable regulatory requirements (IVDR) and get insight on the concepts established in the ISO 13485:2016 for Quality Management Systems of players in the IVD medical device field, all while gaining proof of competence from subject matter experts. Content:

• Opening remarks • ISO 13485:2016 QMS requirements for regulatory purpose

o New elements o Management Responsibility o Resource Management o Product Realization o Measurement, analysis, and improvement

• QMS according to IVDR, (EU) 2017/746 o New compared to the IVDD, 98/79/EC o Economic Operators o Technical Documentation, incl. Performance Evaluation o Conformity Assessment o PMS, and Vigilance

• Relations between ISO 13485:2016 and IVDR • Q&A session • Closing remarks

Target group: Quality Managers, Quality Assurance Professionals, Auditors, Consultants, IVD Medical Device Professionals in general Location: Virtual Training Language: English




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MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) TRAINING

Description and benefits: The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to combine the requirements of 5 jurisdictions within a single audit. Currently, Australia, Brazil, Canada, Japan, and the United States are participating in the program. In this training, the background of MDSAP, the concept and the audit process including grading of non-conformities and post-audit follow-up activities will be introduced to you. Within 4 hours, you will receive a comprehensive summary concerning the fundamentals of the MDSAP and the potential advantages of adhering to the program. Furthermore, you will receive expert tips on how you can prepare your organization in the most efficient manner.

Content: • Opening remarks• Introduction to MDSAP Background/Concept/Participating countries• MDSAP Audit Model• MDSAP Audit Process• Audit Time Calculation• MDSAP Grading• Post-Audit Follow-up Activities• Q&A session• Closing remarks

Target group: Quality Managers, Quality Assurance professionals, Quality Engineers, Auditors, Regulatory Affairs professionals, Consultants, Medical Device professionals in general

Location: Virtual Training Language: English






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INTERNAL AUDITS ACCORDING TO ISO 13485/MDR/ISO 19011 Description and benefits: The Auditing Management Systems allow economic operators of medical devices to drive an activity across the entire audit workflow from planning to reporting. In this training, the background of the Auditing Management System including the principles of auditing, managing an audit program, conducting management system audits, and evaluation of competence of the individuals involved in the audit process will be introduced to you. Within 8 hours, you will receive a comprehensive summary concerning the fundamentals of the Auditing Management and the potential advantages of adhering to the program. Furthermore, you will receive practical examples of how to write the audit report and of typical ISO 13485:2016 and Medical Device Regulation (MDR) nonconformities. Content:

• Opening remarks • Introduction • Types of Audits • Auditing Principles • Managing and Audit Program • Conducting an Audit • Competence and Evaluation of Auditors • Audit Sampling and Non-conformity identification • Practical examples • Q&A session • Closing remarks

Target group: Quality Managers, Quality Assurance professionals, Quality Engineers, Auditors, Regulatory Affairs professionals, Consultants, Medical Device professionals in general Location: Virtual Training Language: English




QUNIQUE Quality Management



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INTERNAL AUDITS ACCORDING TO EU IVDR 2017/746

Description and benefits: The Auditing Management Systems allow economic operators of in vitro diagnostic devices to drive an activity across the entire audit workflow from planning to reporting. In this training, the background of the Auditing Management System including the principles of auditing, managing an audit program, conducting management system audits, and evaluation of competence of the individuals involved in the audit process will be introduced to you. Within 8 hours, you will receive a comprehensive summary concerning the fundamentals of the Auditing Management and the potential advantages of adhering to the program. Furthermore, you will receive practical examples of how to write the audit report and of typical In Vitro Diagnostic Regulation (IVDR) nonconformities.

Content: • Opening remarks• Introduction• Types of Audits• Auditing Principles• Managing and Audit Program• Conducting an Audit• Competence and Evaluation of Auditors• Audit Sampling and Non-conformity identification• Practical examples• Q&A session• Closing remarks

Target group: IVDR specialists, Regulatory affairs professionals, Quality management professionals, Internal Auditors, Consultants, In Vitro Diagnostic Device professionals in general





QUNIQUE Regulatory Affairs F OC U SE D ON S O L U T I O N S


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EU MDR 2017/745 GENERAL PUBLIC TRAINING Description and benefits: The medical device regulation was published in 2017 with a transition period three years. Due to COVID-19 a delay of 1 year was applied by the EU Legislators ensuring a reasonable implementation of the regulation. Notified bodies will require training records of your resources when conducting initial certification audits of your organization. Don´t wait long and use the additional year to get your resources prepared. Content:

• Opening remarks • History and update about the status of implementation • Economic Operators and their obligations • Classification • Conformity Assessment Process • Technical Documentation • Clinical Evaluation • Post-Market Surveillance and Reporting Requirements • Q&A session • Closing remarks

Target group: Regulatory Affairs professionals, R&D professionals, Quality Management and Assurance professionals, Auditors, Consultants, Medical Device professionals in general Location: Virtual Training Language: English






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欧盟医疗器械法规（MDR）培训课程介绍

欧盟医疗器械法规（medical device regulation, MDR）于 2017 年发布并提供了三年过渡

期。受新冠肺炎疫情影响，欧盟立法机构将医疗器械法规生效时间推迟一年，以确保法规的

合理执行。公告机构在对您的机构进行初始认证审核时，将会要求您提供相关人员的培训证

明。欢迎您注册我们的 MDR培训课程，用这额外的一年给相关人员做好准备吧！

课程涵盖内容：

• 简介

• 背景以及法规执行现状更新

• 经济运营者及其义务

• 产品分类

• 符合性评估程序

• 技术文档

• 临床评估

• 上市后监管以及报告要求

• 问答环节

• 结语

本课程适用于：法规事务专业人员，研发专业人员，质量管理和质量保证专业人员，审核

员，咨询顾问，医疗器械专业人员

培训地点: 线上培训

语言: 中文

价格: 999欧元培训时长: 8小时

培训证书: 以PDF形式提供

培训课件: 以 PDF形式提供




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EU IVDR 2017/746 GENERAL PUBLIC TRAINING Description and benefits: The in-vitro diagnostic medical device regulation (IVDR) 2017/746 was published in 2017. It applies from May 2022. In this training, attendees will gain a comprehensive understanding of the EU IVDR, including the requirements, changes, new roles, and the various aspects needed for manufacturers to fully achieve compliance with the new regulation. The training covers the entire production phase from pre to post-market and the different steps in between. Content:

• Opening remarks • History and update about the status of implementation • Economic Operators and their obligations • Device Classification • Technical Documentation • Performance Evaluation • Conformity Assessment • Post-Market Surveillance, and Vigilance • Transparency under the IVDR (Eudamed) • Lab Developed Tests • Quiz • Q&A session • Closing remarks

Target group: Regulatory Affairs and Quality Management professionals, R&D, production, and project management professionals directly involved in implementing the regulations, Authorised representatives, Importers/ Distributors, Consultants, Medical Device professionals in general Location: Virtual Training Language: English






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EU IVDR 2017/746 PERFORMANCE EVALUATION TRAINING Description and benefits: The in-vitro diagnostic medical device regulation (IVDR) 2017/746 was published in 2017. It applies from May 2022. It contains new, detailed requirements on Performance Evaluation, which trigger activities for the demonstration of conformity prior to launch as well as for continuous performance follow-up after launch. All your claims must be backed up with clinical data. This training will provide you with the needed information in order to achieve a good performance evaluation in reference to the EU IVDR including the performance characteristics, the requirements, scientific validity and others. Attendees will benefit from an extensive view of the performance evaluation, its methodology and requirements as well as an understanding of its importance. Content:

• Opening remarks • Introduction to IVDR • GSPR 9: Performance Characteristics • Performance Evaluation Requirements • Scientific Validity • Analytical Performance • Clinical Performance • Performance Studies • Post-Market Performance Evaluation • Eudamed Module on Clinical Studies • Quiz • Q&A session • Closing remarks

Target group: Quality Assurance professionals, Regulatory Assurance professionals, R&D scientists and professionals, Consultants, Medical Device professionals in general Location: Virtual Training Language: English






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EU MDR 2017/745 AND IVDR 2017/746 PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE TRAINING

Description and benefits: The Person Responsible for Regulatory Compliance (PRRC) is a new and critical role under the MDR and IVDR. As this is a new expectation of the incoming regulations, many manufacturers have questions regarding what the requirements are applying to their organization. PRRCs under the new regulations will have responsibilities regarding the Declaration of Conformity (DOC), technical documentation, post-market surveillance (PMS) and reporting (vigilance, serious incidents, trend reporting and field safety corrective actions (FSCA)) as well as clinical investigations. In this training session, you will gain a detailed understanding of the requirements under Article 15 for the responsibilities of a PRRC, expectations of MDCG 2019-7 and have confidence in your strategy to fulfil the new requirements. Content:

• Opening remarks • Introduction to EU MDR / IVDR • Responsibilities of PRRC under EU MDR and IVDR and examples of involvement in

organization • Requirements and considerations for manufacturers and assignment of a PRRC • MDCG 2019-7 Guidance on Article 15 • Q&A session • Closing remarks

Target group: Aspiring or Future PRRC, Regulatory affairs professionals, Quality management professionals, Authorized representatives, Consultants, Medical Device professionals in general Location: Virtual Training Language: English






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EU MDR 2017/745 POST-MARKET SURVEILLANCE TRAINING Description and benefits: Post-Market surveillance (PMS) serves as a key process in the EU MDR. PMS will have additional requirements and undergo additional scrutiny in the incoming regulations. In this training session, you will understand how to gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime of the device to demonstrate conformance to the EU MDR actively and systematically. This training will prepare you for the smooth integration of PMS in day-to-day operations and help you fully understand the changes to the PMS and PMCF requirements caused by the new EU MDR. Content:

• Opening remarks • Introduction to EU MDR • Requirements presented under EU MDR for PMS • PMS Plan, PMS Report, PSUR and linkage to SSCP • Considerations and common issues for PMS • How to streamline your approach to PMS under EU MDR • Linkage to the QMS requirements and EUDAMED • Q&A session • Closing remarks

Target group: Regulatory affairs professionals, Quality Assurance professionals, Medical device marketing and sales professionals, patient safety or customer service representatives, Consultants, Medical Device professionals in general Location: Virtual Training Language: English






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EU IVDR 2017/746 POST-MARKET SURVEILLANCE TRAINING Description and benefits: Post-Market surveillance (PMS) serves as a key process in the IVDR. PMS will have additional requirements and undergo additional scrutiny in the incoming regulations. In this training session, you will gain an understanding of how to gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime, specifically through insight on the changes in reporting responsibilities, including post-market surveillance follow-up (PMPF), to demonstrate conformity to the IVDR actively and systematically. The training also gives you an opportunity to discuss the various topics within post-market surveillance responsibilities with a subject matter expert whilst also receiving training evidence which demonstrates your competence. Content:

• Opening remarks • Introduction to IVDR • Requirements presented under IVDR for PMS, including PMPF • Considerations and common issues for PMS • How to streamline your approach to PMS under IVDR • Q&A session • Closing remarks

Target group: IVDR PMS Managers, Vigilance Managers, Regulatory affairs professionals, Quality management professionals, Consultants, Medical Device professionals in general Location: Virtual Training Language: English






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ECONOMIC OPERATORS' OBLIGATIONS TRAINING Description and benefits: The Medical Device Regulation (MDR) specifies categories of economic operators that have specific obligations defined per Article 2 which include manufacturers, authorized representatives, importers, distributors and operators which sterilize or assemble procedure packs or systems under Article 22(1) and 22(3) (MDR requirement). In this training session, you will gain a detailed understanding of the obligations in the context of the MDR and IVDR under Articles 10 to 14 for economic operators and of the importance of engaging competent organizations in your supply chain. The training will allow you the opportunity to engage with the trainer and discuss topics which regard the economic operators' responsibilities as well as gain training evidence to demonstrate competence in your role as an economic operator. Content:

• Opening remarks • Introduction to EU MDR • Roles of each economic operator under the EU MDR • Requirements and considerations for economic operators • Q&A session • Closing remarks

Target group: Regulatory affairs professionals, Quality management professionals, Importers/distributors, Authorized representatives, Consultants, Medical Device professionals in general. Location: Virtual Training Language: English






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ISO 14155:2020 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS UPDATE – BRIDGING THE WAY TO THE EU MDR

Description and benefits: The ISO 14155:2020 is the third edition and introduced higher requirements to conduct clinical investigations of medical devices for human subjects with regards to the EU MDR 2017/745 and ISO 14971:2019 – Application of risk management. To ensure that you are fulfilling the requirements of this international standard on the road to MDR, we are offering detailed insight about the requirements, their backgrounds, and links to risk management and MDR as well as the best way to show compliance. This training will help you facilitate your gap analysis by obtaining the knowledge to plan the implementation process of the standards and understand the key elements required to plan and conduct the clinical investigation Content:

• Opening Remarks • Why do we need more and more clinical data and clinical investigation? • Overview of main changes in ISO 14155:2020 • Ethical considerations • Clinical investigation planning • Conducting clinical investigations • Suspension, termination, and close-out of the clinical investigation • Responsibilities of the sponsor • Responsibilities of the principal investigator • New Annexes (normative & informative) • Q&A session • Closing remarks

Target group: Clinical, regulatory, and marketing personnel of medical device manufacturers, Clinicians & clinical research personnel at investigation sites, Consultants, Medical Device professionals in general Location: Virtual Training Language: English






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CLINICAL EVALUATION UNDER THE EU MDR 2017/745 Description and benefits: The Medical Device Regulation EU MDR 2017/745 introduced higher requirements for clinical data and the clinical evaluation process. To ensure that you are fulfilling the requirements on the road to MDR, we are offering detailed insight about the requirements, their backgrounds and links to risk management, post-market surveillance (PMS), post market clinical follow-up (PMCF) and MDR as well as the best way to show compliance. This training provides you with insight on the various stakeholder interactions within the evaluation process, the importance of the state-of-the-art establishment, identification and appraisal of pertinent data while giving you the needed methodologies for the clinical evaluation report. Content:

• Opening remarks • What can influence and drive the clinical evaluation and vice versa? • Which information is necessary to start the clinical evaluation? • What are the differences and requirements of the clinical development plan (CDP)

and clinical evaluation plan (CEP)? • Structure and content of the clinical evaluation report (CER) • Device description requirements • Establishment of the state-of-the-art • Identification and appraisal of pertinent data (literature search report • Requirements for the analysis of clinical data including legacy devices • Requirements for the analysis of performance and safety claims of the device • Requirements for PMS/PMCF activities throughout the expected lifetime of the

device • Establishment of the benefit/risk ratio • Q&A session • Closing remarks

Target group: Clinical, medical, and regulatory personnel of medical device manufacturers, Consultants, Medical Device professionals in general Location: Virtual Training Language: English




QUNIQUE Regulatory Affairs



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PATHWAY TO THE U.S. MARKET - HOW TO PREPARE A SUCCESSFUL 510(K) FOR YOUR DEVICE

Description and benefits: In this training session, you will learn how to bring Class II devices to the U.S. market under the 510(k) program. Topics such as device classification, the concept of substantial equivalence, device specific guidelines, choosing a 510(k) pathway, preparing a 510(k) submission and how to submit a e-copy compliant 510(k) submission to FDA will be discussed. This training session does not require any prior knowledge of US medical device regulations and will give you the information required to prepare your first 510(k) or to improve your next 510(k). Through this training, you will learn to develop a submission strategy as well as how to draft a 510(k) with a lean efficient approach.

Content: • Opening remarks• Background of 510(k) program• 510(k) Pathways• Device Classification• Drafting the 510(k) Sections• Incorporating relevant FDA guidance and usage of consensus standards• Submitting a 510(k) to FDA• Responding to deficiency letters• Q&A session• Closing remarks

Target group: Regulatory affairs professionals, Quality management professionals, Consultants, Medical Device professionals in general








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EUDAMED TRAININGDescription and benefits: The Eudamed database are a revolutionary IT platform which allows the monitoring of medical and in vitro diagnostic devices according to the new European regulations. This platform has been set with the aim of achieving better transparency and allows for easier post-market tracing. In this training provided by EudaMed.eu, the only company to have directly worked with the European Commission on the MDR Eudamed, attendees will be able to save months of research and instead gain a fully comprehensive view of Eudamed and its requirements in two half days, giving them the ability to guide MDR Eudamed strategies, navigate the requirements, update online UDI data, guide the data preparation, and assess skill gaps.

Content: • Opening remarks

o Eudamed timeline and data submission optionso Manual uploadso Machine-to-Machineo Data Exchangeo Available data serviceso Data rules and formatso Record versioning - service impactso Data Exchange

• Actor registration - EUDAMED input screens• Device registration - EUDAMED input screens

o MDRo IVDRo SPP

• EC published artefactso Data dictionary and data fields

• Eudamed.eu services• Q&A session and closing remarks

Target group: Regulatory Affairs and Quality Assurance professionals, IT, Consultants, and EUDAMED interested people.

Date: 26/27.01.2021 Language: English

Time: 14:30 to 19:00 PM CET Duration: 8 hours

Location: Virtual Training Presentation: To be provided in PDF

Price: 995 € Certification: To be provided in PDF





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INTERNATIONAL REGULATORY AFFAIRS TRAINING FOR MEDICAL REGISTRATIONS

Description and benefits: In this training module, you will learn how to bring medical devices to the international markets for Australia, Brazil, Canada, China, Japan, Korea, Russia, and Singapore. This training will give an in-depth overview of quality system requirements, device classification, developing regulatory strategy, submission requirements and post market surveillance. This training session does not require any prior knowledge of international medical device regulations and will give you the information required to prepare your first submission to select international markets. By the end of the training, you will understand regulatory requirements for select regulatory jurisdictions and the relevant quality system requirements. You will also understand how to select and prepare regulatory strategy based on available premarket pathways as well as comprehend submission requirements and processes based on the chosen regulatory strategy and understand the applicable post-market requirements

Content: • Opening remarks• Background of regulatory requirements• Current applicable medical device regulations• Quality system regulations• Selecting and preparing regulatory strategy• Preparing and submitting medical device submissions• Post-market requirements• Q&A session• Closing remarks

Target group: Regulatory affairs professionals, Quality management professionals, Consultants, Medical Device professionals in general





QUNIQUE GmbH is a consultancy which is specialized in developing tailoredconcepts and solutions to support, maintain and improve the compliance ofcompanies in the medical, in-vitro diagnostic and combination device sectors.QUNIQUE’s core competency is the exact knowledge of the requirements andneeds of the various stakeholders including manufacturers in the different fields(e.g. IVDR, MDR, MDSAP, ISO13485 updates).

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Quality and Regulatory Consultancy - E V E N T S 2 0 2 1 · 2021. 6. 4. · Regulatory Affairs EU...

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