2- Day Training for RA/QA Professionals of the MD Industry:
The Regulation (EU) 2017/746 for IVD Devices
The European Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices was published on May 5th, 2017 and entered into force on May 25th, 2017. With May 26th, 2022 as the application date for the Regulation (EU) 2017/746; there is not a lot of time left for In Vitro Diagnostic (IVD) Medical Device companies to get up to speed. GMED North America. has designed a comprehensive training course to help companies prepare for their application to obtain and/or maintain CE marking for their In Vitro Diagnostic medical device product(s) and :
- Gain an understanding of the changes introduced by the European Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices;
- Assess the impacts of those changes on their organizational and structural activities;
Over the course of these 2 days, the attendees will learn about the new requirements to plan an efficient transition and ensure they are ready to:
- Address the new Quality Management System (QMS) requirements;
- Understand the IVD Product Classification criteria’s and Conformity Assessment routes and how it applies to their IVD device(s);
- Assess the impacts on the Technical Documentation for In Vitro Diagnostic Medical Devices in relation with Product Classification criteria’s and Conformity Assessment routes;
- Identify the expectations with respect to the Clinical Data(s), Clinical Performance Evaluation(s) and Risk Management;
- Implement the requirements for labelling , the Unique Device Identification (UDI) and EUDAMED;
- Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.);
Sign up today and join our intensive 2 day course on the new European Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices. Acquire a solid foundation so that you and your team are prepared to tackle through practical cases and working sessions/discussions led by our Expert lead auditor, these new challenges.
Keywords: European Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices, IVDs, In Vitro Diagnostic, IVDR, Quality Management System (QMS) ,ISO 13485:2016, Notified Body, Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Clinical Evaluation and Clinical Data, Post Market Surveillance, Vigilance reporting.
WHO SHOULD ATTEND
- Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
- Internal and external Auditors
- Good knowledge and effective practice of the Directive 98/79/EC;
- Familiar with the general principles of the European Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices;
The maximum number of participants per training session is set to 18 to guarantee a stimulating and practical working environment.
- Presentations in PDF and binder copy of the European Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices;
- Practical working sessions and group discussions ;
- Course evaluation;
- Lunch meeting with the trainer (Lead Auditor for In Vitro Diagnostic Medical Devices)
|Training content and objectives|
|DAY 1 & 2: EU IVDR 2017/745|
|8:30 am to 9:00 am||Breakfast|
|9:00 am – 12:15 pm||
|12:15 pm - 1:00 pm||Lunch|
|1:00 pm- 5:00 pm||
Program + Practice session
Note: GMED North America retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.
|About the trainer|