Your CAPA and Complaint Records
Will Be the First Thing FDA Pulls
Are They Ready?
CAPA · Complaint Investigation · MDR Evaluation · Record Linkage
Why This Matters Under QMSR
Under QMSR, FDA inspectors do not review records in isolation. They trace one record through every linked procedure,
training document, effectiveness check, and change control event connected to it. Most medical device sites do not know
where that thread breaks until an investigator is already in the room asking for records, they cannot produce cleanly.
What a Senior Medvacon Consultant Reviews
Three CAPA
- Root cause documented and defensible
- Actions linked to procedures and training
- Effectiveness verification retrievable
- Full thread producible under inspection
Three Complaints
- Investigation complete and documented
- MDR evaluation documented, device specific
- CAPA linkage traceable where required
- Trending evidence present and retrievable
Three Deliverables — Focused on Inspection Exposure
QMSR Inspection Thread Scorecard
Red, yellow, green ratings across six FDA inspection risk dimensions specific to your CAPA and complaint records.
Visual and immediately readable by leadership.
Fix These First Action List
Three to five specific prioritized actions in plain language, sequenced by inspection risk. Not regulatory citations.
Not general recommendations. Specific things your team can act on immediately before your next FDA inspection.
Executive Summary
One page. What we found, what it means if FDA walks in tomorrow, and what needs to move
first. Written so leadership can act on it immediately.
| Delivery | Timeline | Who Delivers | Records Required |
| Fully Remote | Five Business Days | Senior Consultant | Six, Sent Remotely |
Method and materials remain proprietary. Details, pricing, and timing are provided on a quick call.