An expert gap analysis of your risk management file
Reviewed against ISO 14971, delivered within five business days.
A personalised review of your risk documentation against ISO 14971. We look at your actual files, your hazard analysis, risk assessments and mitigations, then send you a written gap report showing where your risk file holds up and where an auditor would push back.
Priced at $5,000. Your gap report and 30-minute debrief land within five business days.
Thanks, your request is in. We will email you the mutual NDA the same day and get started.
Risk file gap report
A written report on your risk management file. Missing or incomplete hazards, risk controls with no evidence of implementation, and mitigations that were never verified.
Traceability check
We check whether your risk controls trace back to requirements and forward to verification, the exact link an auditor always asks to see.
30 minute expert debrief
A live session with one of our experts to walk you through the findings and what to fix first.