FDA · Inspection · GCP
FDA audit preparation, before the inspector arrives.
An FDA inspection is won in the months before it. Know what the FDA examines, how to build an inspection-ready trial master file, and how to run the day itself.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Inspection-ready, by design.
An audit is not a document exercise the week before. Ours are built inspection-ready from first patient in.
Dr Mark Da Costa
Cardiac surgeon and former lead Notified Body reviewer at TÜV SÜD. 400+ devices CE-certified.
in LinkedIn
Charline Petitdemange
ISO 14155 study conduct, EUDAMED registration and multi-country site monitoring across Europe.
Awards, funding, accountability
Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →The preparation
What the FDA actually checks.
FDA inspections of device studies run through the Bioresearch Monitoring (BIMO) program, against 21 CFR Part 812 and related requirements. Preparation is about making every one of those areas traceable.
01
What the FDA examines
An FDA inspection focuses on a consistent set of areas: informed consent, adherence to the protocol and investigational plan, source data and its verification, IRB approvals, device accountability, and adverse-event reporting.
The inspector’s checklist
- Informed consent obtained and documented before procedures
- Protocol adherence and deviation handling
- Source data supporting every case report form entry
- Device accountability and IRB records
- Timely, complete adverse-event reporting
02
An inspection-ready TMF
The Trial Master File is what the inspector reads. Inspection readiness means it is complete, current and internally consistent throughout the study, with an audit trail under 21 CFR Part 11 for anything electronic. A TMF assembled retrospectively rarely survives scrutiny.
03
Source data and Part 11
Findings cluster around source data: entries in the case report form that cannot be traced back to a source, or electronic systems without a validated audit trail. A validated EDC to 21 CFR Part 11, with source-data verification built into monitoring, closes the most common gaps.
04
The day itself
On inspection, preparation shows: a named host, a clear document-request process, staff who can speak to their own records, and answers that match the file. We run mock inspections so the real one holds no surprises.
FDA readiness
Won before it starts.
Talk to a specialist
Would your study survive an FDA inspection today?
Book a free scoping call. We run a readiness review and, if you want, a mock inspection, so the real one holds no surprises.
Book a free scoping callThe best time to prepare for an FDA audit was first patient in.
An expert read checks your consent, source data, TMF and Part 11 trail against what the FDA examines, and closes the gaps before the inspector finds them.
Book a readiness reviewQuestions we hear first