What you'll learn
Definitions and objectives of PMS & PMCF in-line with EU MDR
Fundamentals of PMS and PMCF to build basic foundation
EUMDR expectations of data sources, data types and data utilization
Planning of data collection and data analysis
Methods of data collection and data analysis
Documentation requirements of EU MDR
Gain confidence in preparing PMS-related documents by building the right foundation
Requirements
No advanced expertise or prior experience on PMS/PMCF documentation required.
Familiarity with the EUMDR framework is a plus, but not required (The course introduces key articles and annexes pertaining to PMS & PMCF).
Basic understanding of medical devices preferred (e.g., what they are and how they are regulated).
General knowledge of Quality Management Systems (QMS) or ISO 13485 is an advantage.
Description
This comprehensive course covers the fundamental concepts and core principles of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) as required by the EU Medical Device Regulation (MDR 2017/745).Gain a clear understanding of how PMS and PMCF processes fit into the overall regulatory framework and their critical role in ensuring the continued safety and performance of medical devices throughout their lifecycle. Dive deeper into practical aspects of data sources and objectives manufacturers must fulfil by utilizing right set of data and linking them with the right set of methods for analysis and conclusions. As you progress further into the course, you'll learn to identify similarities and differences between PMS and PMCF processes, which comes in handy if you ever develop these processes right from scratch! The course contents continuously highlight relevant portions from the EU MDR, unfolds regulatory requirements in a thoughtful and logical sequence and draws a parallel between PMS and PMCF as the lectures progress. I strongly recommend this course to: All MedTech professionals who are directly connected with regulatory intricacies in their day-to-day profileAll MedTech professionals involved in driving CE marking for the company's portfolio All those professionals keen to explore PMS/PMCF requirements for EU compliance By the end of this course, the students will be able to gain greater level of confidence in driving PMS/PMCF intricacies in their roles!
Students & Graduates - Eager to build a foundation in regulatory affairs (medical devices),Entry to Mid-level RA/QA Professionals – Wishing to strengthen knowledge of EUMDR, PMS & PMCF,Experienced Professionals – Looking to refresh concepts and/or adapt another perspective,Medical Device Start-up Teams and Entrepreneurs – Seeking clarity on regulatory obligations to fulfil after obtaining CE Mark for Europe,Medical Device Professional from other Manufacturing Functions - For gaining new skills to add to their profile or planning to shift to regulatory affairs

https://rapidgator.net/file/dbbc189cdcf16cc665daf602dceb4a1d/Beyond_the_CE_Mark_PMS_PMCF_Decoded.rar.html