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Leading the clinical evaluation and notified body response strategy for the EU MDR certification of a Class IIa digital health platform
What we did:
Led the clinical evaluation strategy for an EU MDR 2017/745 Class IIa Software as a Medical Device (SaMD).
Rebuilt the Clinical Evaluation Plan and Report and structured the manufacturer's response to open notified body queries.
Designed and executed state-of-the-art and device-specific literature reviews across five clinical indications.
Impact:
Delivered a self-contained clinical evidence package spanning five indications.
Provided an updated regulatory strategy better aligned with notified body expectations.