Date 14 March 2018
Time: 08:00 – 10:00 AM PST
Speaker: Keith Morel
Topic: Post Market Surveillance and Post Market Clinical Follow up (PMS/PMCF) under MDR 2017/745
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)
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 & 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.
For more information and registration, check here.