UC-420
EU MDR Technical File Currency Watch
Holds every technical file section against its cited evidence, flags what has gone stale, and drafts the periodic regulatory updates.
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The Challenge
Technical files drift out of date between audits and one notified body finding can stop a whole product family shipping. Evidence sits with clinical, quality and marketing teams and no one owns the whole file.
How It Works
- Reads technical file sections, clinical evaluation reports, surveillance plans and standards.
- Checks each section against its cited evidence and flags superseded standards and stale data.
- Sends the regulatory owner a currency register and drafted text before the surveillance audit.
What It Removes
- Manual annual sweeps of every technical file section
- Rebuilding the clinical evaluation search from scratch
- Spreadsheet tracking of notified body finding closure
Input Data RequirementsTechnical file sections, clinical evaluation reports, surveillance plans, complaint and vigilance data, standards lists, notified body findings
Output FormatSection-by-section currency register, drafted periodic safety update and follow-up text, superseded-standard alert list, audit pack per device family
“The file was right the day we certified it, and two standards have moved since without telling the section owner”