Post Market Surveillance and Vigilance
Implement the new requirements under the EU MDR and IVDR
1-day training session | Virtual Classroom
About the training
Both Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) include new and more detailed Post-market surveillance and vigilance requirements.
The transitional provisions described in both Regulations (MDR Article 120, IVDR Article 110), require a manufacturer to implement the Post-market surveillance, market surveillance, vigilance requirements during the transitional period in order to keep placing its Device on the market with a Medical Device Directive certificate after the date of the Regulations application.
This course has been designed to allow manufacturers to easily identify the key requirements and prepare for their timely implementation.
REQUIRED LEVEL
Basic knowledge of the post-market requirements under the Directives 93/42/EEC, 90/385/EEC and 98/79/EC
Florianne Torset-Bonfillou Senior International Regulatory Project Manager; Lead Auditor & Product Reviewer, GMED North America
Florianne is a Senior International Project Manager at GMED North America. She is also a Lead Auditor and a Product Reviewer with focus on high-risk devices, mainly in the cardio and neurovascular field.
She has a background in Biology, Chemistry and Quality Management. After working in the Pharma/Device industry, Florianne first joint GMED as an Assessor, then became part of the Quality & Regulatory support team. For the past 5 years, Florianne provided Regulatory support to the local team for the transition to the European Regulation EU 2017/745 and EU 2017/746. Since 2023, she supports the UK subsidiary towards its UKCA designation.
She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.
Who Should Attend
- Medical Device Manufacturers: Regulatory Affairs Managers, Quality Managers, Person in Charge of Regulatory Compliance
- Internal and External Auditors
- Importers
- Distributors
Learning Objectives
- Identify regulatory requirements with regards to Post Market Surveillance and Vigilance
- Implement new Post-Market Surveillance and Vigilance requirements under Regulations (UE) 2017/745 and (UE) 2017/746
- Identify tools and forms to be used, methods to implement
Educational Resources
- Presentations
- Practical working sessions
- Course evaluation
Check out the Program
- Post Market Surveillance and Vigilance requirements
- Analysis of new requirements
- EUDAMED Vigilance module
- Transitional provisions – Notified Body’s expectations
- Implementation: PMS plan, PSUR, PMCF… (tools, forms, methods)
- Role of the Notified Body – new activities
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