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
30.60.90 Readiness Roadmap
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
Fully Remote
Timeline
Five Business Days
Who Delivers
Senior Consultant
Records Required
Six, Sent Remotely