The sold-out webinar on PMS and PMCF under the MDR 2017/745 with the Organization of Clinical and Regulatory Associates (ORCA) on March 14, 2018 was a lively and detailed discussion. Many of the confusing topics surrounding the definitions of PMS and PMCF under the MDR, were discussed, including how to develop a PMCF “process” and its distinction from both a PMCF “study” and PMCF “investigation”. Examples of study designs were discussed including manufacturer-initiated clinical investigations, collecting device registry data or using a questionnaire to collect clinical safety and performance information. We also discussed the various new plans and reports which will be required, estimated the additional resources needed to remediate and then maintain those documents, and finally described how PMCF fits into the other QMS processes and systems under the MDR. A broad audience from device manufacturers, CRO, and independent consultants enjoyed the presentation and related Q&A session.
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Keith: “It was great to share our take on MDR requirements regarding PMCF with such a diverse audience and to answer their questions. These next few years is a “golden window” manufacturers have to use PMCF data collected under their MDD certificates to close any “gaps” that exist between your current clinical data and evaluation and the requirements of the MDR. We’ll be happy to help clients identify those gaps and develop & implement PMCF plans, under the MDD, MDR and, importantly, in the transition from the one to the other".
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