A post-market surveillance (PMS) system is a tool for monitoring and assessing the safety and performance of in vitro diagnostic (IVD) medical devices throughout their entire life cycles. It consists of a set of ongoing activities, conducted by manufacturers, to collect and evaluate the experiences gained from devices that have been placed on the market. It is used to identify potential risks and to trigger appropriate preventive and corrective actions.
A PMS system is a critical regulatory requirement under the IVDR and an essential part of a quality management system (QMS) (Article 10(8)). It links with and overlaps other QMS processes and documents.
This webinar will outline the concept, requirements, methods and best practices for implementing a compliant and effective PMS system, including the elements specified in IVDR Annex III I. You will learn the types of data that should be considered in the PMS process, methods for data evaluation and the regulatory expectations for implementing preventive and corrective actions when necessary (Article 78(3)-(4)). A list of regulatory reference and guidance documents will be provided to facilitate further understanding and correct application of PMS requirements.
Agenda
- Introduction to PMS under the IVDR
- Key elements and documents of a PMS system
- PMS requirements for various risk classes and legacy devices
- Links with other QMS processes and documents
- How to implement and maintain an effective PMS system
- Summary of PMS under the IVDR
- Regulatory guidelines and references
- Q&A
Target Audience: The webinar is intended for
- In vitro diagnostic medical devices manufacturers worldwide, including corporations, SMEs and startups
- Persons responsible for regulatory compliance (PRRC)
- EU authorized representatives
- Regulatory affairs managers and their teams
- Quality managers and their teams
- Technical directors and their teams
- R&D managers and their teams
- Validation managers and their teams
Language: English
Cost: No Charge
