Post-Market Surveillance Requirements for Medical Devices and IVDs
Post-Market Surveillance Requirements for Medical Devices and IVDs
Learn more about the regulatory requirements for post-market surveillance (PMS) under MDR and IVDR.
On demand
1h
Medical Devices & IVD
English
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Description
This webinar on demand will explain how PMS includes all the activities carried out by the manufacturer to monitor, measure, and assess the device’s quality, performance and safety to ensure that the benefit-risk profile of the device remains current.
We will also briefly dive into the concept of Post Market Clinical Follow-up (PMCF) for medical devices and Post-Market Performance Follow-up (PMPF) for IVDs.
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What you'll learn
- Understand the PMS requirements imposed by the MDR and IVDR
- Gain a basic understanding of PMPF and PMCF
- Know what needs to be created in terms of plans and reports
Speakers
Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.
Don’t miss the opportunity to learn and engage with professionals in the field.
Kirsten Van Garsse
Direcor Representative Service & Manager IVD Regulatory Affairs
Kirsten Van Garsse obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has amassed extensive experience in the In Vitro Diagnostic Medical Device Industry. She joined Qarad, now part of the QbD Group, a consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, at the end of 2017.
In her role as Director of Authorized Representative Services & Manager of IVD Regulatory Affairs, Kirsten applies her wealth of experience to Regulatory Affairs projects, adeptly translating regulations into compliant business processes and applications. Additionally, she oversees the various Representation Services offered by Qarad, ensuring clients receive expert support in navigating regulatory requirements.
Anne-Sophie Grell
Manager Regulatory Affairs Medical Devices
Anne-Sophie Grell – PhD in Physics and expertise as a Medical Physicist – brings over 20 years of invaluable experience in the areas of Medical Device Quality Assurance (QA) and Regulatory Affairs (RA). As a seasoned Regulatory Affairs Manager, she has consistently demonstrated her proficiency in navigating the complex landscape of medical device regulations. With her extensive knowledge and comprehensive understanding of the industry, Anne-Sophie is a respected authority in ensuring compliance and driving successful outcomes in medical device regulatory affairs.
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