Risk Management SOP — ISO 14971, ISO 13485, MDSAP & FDA QMSR Compliant

Risk management is a foundational requirement for medical device manufacturers — and one of the most scrutinized areas in ISO 13485 audits, MDSAP assessments, and FDA inspections. Without a structured, documented approach aligned with ISO 14971:2019, gaps in your risk management process can jeopardize certification, market access, and patient safety.

This Risk Management SOP package gives your quality and regulatory team a complete, audit-ready framework to plan, execute, and document risk management activities across the entire device lifecycle — fully aligned with ISO 14971:2019, ISO 13485:2016, MDSAP, and FDA QMSR (21 CFR Part 820).

What’s included:

• P-02 Risk Management Procedure — step-by-step instructions covering risk management planning, risk analysis, risk evaluation, risk control, residual risk assessment, and post-production information requirements
• F02-1 Risk Management Plan — pre-formatted, editable template to define the scope, responsibilities, and activities for each device or project
• F02-2 Risk Management Report — structured template to document the overall conclusions of the risk management process and confirm acceptability of residual risks
• F02-3 Hazard Analysis — ready-to-use template to systematically identify hazards, hazardous situations, sequences of events, and estimated risks

Who Is This For

Quality managers, regulatory affairs professionals, and risk management team members at medical device companies seeking ISO 13485 certification, preparing for MDSAP audits, pursuing CE marking under MDR, or maintaining FDA QMSR compliance.

Why This SOP and Not Starting from Scratch

Building a compliant risk management procedure and the associated templates from scratch takes 8–15 hours of a regulatory professional’s time. This package is immediately usable, written by an experienced ISO 13485 Lead Auditor and former Notified Body auditor — reflecting current notified body and regulatory expectations across EU, US, and Canada.

✓ Instant download after purchase ✓ Fully editable Word format ✓ Compatible with ISO 14971:2019, ISO 13485:2016, MDSAP, FDA QMSR ✓ Updated April 2026 ✓ Used by quality and regulatory teams across EU, US and Canada.

Frequently Asked Questions

Q: Does this package cover the full ISO 14971:2019 risk management process? A: Yes. The procedure and templates cover all phases required by ISO 14971:2019 — from risk management planning through post-production information — and are aligned with ISO 13485:2016, MDSAP, and FDA QMSR.

Q: Is the Hazard Analysis template compatible with FMEA or other risk analysis methods? A: The F02-3 Hazard Analysis template is methodology-agnostic and can be used alongside or integrated with FMEA, FTA, or preliminary hazard analysis approaches.

Q: Is this suitable for both new product development and legacy devices? A: Yes. The procedure and templates are designed to support risk management across the full device lifecycle, including legacy device reviews.

Q: In what format are the documents delivered? A: All four documents are delivered in fully editable Microsoft Word (.docx) format.

Q: Does this cover FDA QMSR (21 CFR Part 820) requirements? A: Yes. The procedure is aligned with the FDA QMSR, which harmonizes with ISO 13485:2016 and references ISO 14971 for risk management.