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The FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation
Why take this course?
As medical device companies expand beyond a single market, documentation becomes the silent deal-breaker. Teams often assume FDA and EU files are fundamentally different — only to discover late in development that they overlap in purpose, diverge in structure, and are audited very differently. This webinar clears the confusion by laying out how FDA medical device files and EU MDR technical documentation really compare, connect, and evolve.
The session explains how Design History Files, Device Master Records, and Device History Records function across the full product lifecycle — and how those same concepts reappear under EU MDR as technical documentation, essential requirements, and declarations of conformity. You’ll see how design control differs from a “snapshot in time” file, why some documents must remain living records, and where teams commonly misalign their US and EU submissions. QMSR-driven terminology changes are addressed directly, so documentation strategies remain future-proof.
If your teams are juggling FDA inspections and Notified Body audits, this webinar brings structure and clarity. It shows how to build documentation in parallel, reduce rework, and support global submissions without duplicating effort. You’ll leave with a clearer mental model of what each file is meant to prove — and how to keep regulators on both sides of the Atlantic satisfied.
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