TOPIC: Post Market Surveillance and Post Market Clinical Follow up (PMS/PMCF) under MDR 2017/745
SPEAKER: Dr. Keith Morel
SPEAKER BIOGRAPHY: Dr. Keith Morel is VP of Regulatory Compliance at Qserve Group, the largest EU based medical device consulting company. He heads up the Redwood City office, which along with the Boston, Amsterdam (HQ) and Nanjing make up Qserve’s main office locations.
He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer) where he was responsible for Internal and External audit processes & execution, Management Review, QMS design & governance and the internal Training process. He was also a Senior Project Manager for DEKRA Certification Inc. for 9 years. During his time at DEKRA he was lead auditor for CE (MDD) & ISO 13485:2003 and performed more than 100 audits & more than 200 Design Dossier/Technical File reviews. He was also DEKRA’s senior cardiovascular product expert, as well as a drug-device combination product expert and he holds an ASQ Certified Biomedical Auditor and a CMDCAS auditor certification.
Dr. Morel has also worked in R&D in the Medical Device industry in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products. He has both a Ph. D. in Plasma Physics (Nuclear Fusion) and a First Class Honours degree in Physics from Imperial College of Science, Technology and Medicine, in the UK.
TOPIC DESCRIPTION:
There is a lot of confusion surrounding the definitions of PMS and PMCF under the MDR 2017/745.The Regulations seems to talk about PMCF as a “process” but also as a “follow-on study” – which is it? What are definitions of PMS and PMCF under the MDR, and how have they changed from today? Does PMCF mean a “clinical investigation”? Which QMS processes need to be linked together with regard to PMS-PMCF, per the MDR? When, who and how do I need to create all the various new plans and reports such as PMS/PSUR, PMCF, CEP/CER, RMP/RMR, SS&CP? How many extra resources will I need to (i) remediate to the MDR requirements and (ii) maintain all these reports (and with what frequency)? All these questions and more will be covered in this webinar.
Questions that you might have that will be answered during this meeting:
- The Regulations seems to talk about PMCF as a “process” but also as a “follow-on study” – which is it?
- What are definitions of PMS and PMCF under the MDR, and how have they changed from today?
Does PMCF mean a “clinical investigation”?
- Which QMS processes need to be linked together with regard to PMS-PMCF, per the MDR?
- When, who and how do I need to create all the various new plans and reports such as PMS/PSUR, PMCF, CEP/CER, RMP/RMR, SS&CP?
- How many extra resources will I need to (i) remediate to the MDR requirements and (ii) maintain all these reports (and with what frequency)?
- What information will be public?
What are the top 3-5 takeaways / lessons that will be learned by attending?
Attendees will learn…
1. … what types of activities can be regarded as PMCF
2. … how to “square the circle” of PMCF being a process AND also a study
3. … how to approximate the number of additional resources needed for remediation and
maintenance of all the new plans and report.
WHO:
Functions: RA/QA/Compliance/Engineering
Levels: From junior staff (who actually execute CER/PMS/PMCF plan and report generation) to senior management (who develop the strategy for CER/PMS/PMCF and how it fits into the overall worldwide regulatory strategy for the product in question)
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification