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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand recording from June 2022.
The EU Medical Device Regulation (MDR) includes a section dedicated to postmarket clinical follow-up (PMCF) stating it must be a continuous process. Under the previous regulatory system, the Directives, PMCF was considered specific to postmarket clinical investigations, but the MDR takes a new approach to PMCF, encompassing other activities and referring to them as general and specific PMCF.
This webcast will take a close look at the requirements relating to general and specific PMCF activities, cover how to document PMCF plans and reports using the MDCG 2020-7 and MDCG 2020-8 templates, and clarify when justifications for no PMCF are appropriate.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Richard Holborow, BSc (Hons) RCCP MSCSTGlobal Head of Clinical Compliance Global Regulatory Compliance TeamBSI Group
Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electrophysiology.
Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.
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