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Case Study

Medical Device: MDR Compliance

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A West Coast medical technology company with an established product portfolio

Key Issues:

Our client required a significant overhaul of their safety department in order to adapt to the newest European regulations (2017/745).


BioPoint was retained to develop and help implement an MDR compliant safety department. BioPoint provided a Sr. Medical Device Safety consultant to perform an analysis of the client’s current MDR safety processes and procedures including the collection of AE’s and product complaints, documentation of safety reports, and the Risk Management matrix, etc.  Following the initial assessment, BioPoint’s consultant partnered with our client’s cross-functional leadership team to help develop a detailed project plan. This plan acted as a “roadmap” to help achieve a compliant and integrated safety reporting system. Our consultant, with the support of assigned internal resources, initiated the execution phase revising Safety/Surveillance SOPs, Risk Management files, as well as developing a subsequent RFP used in the selection of a new database vendor.


BioPoint was successful in helping our client develop a complaint safety environment and provided a new level of confidence going into the next ISO audit.