What documents does a compliant ISO 14971 risk management file need?
What is this resource?
A free, downloadable starter set built against ISO 14971:2019 and mapped to applicable FDA QMSR, EU MDR, ISO 13485 and MDSAP expectations. Each document is structured clause by clause, with guidance notes explaining what auditors look for and where risk management files most often fall short.
Who should use it?
Manufacturers building or remediating a risk management file, and quality and regulatory staff responsible for ISO 14971 compliance across one or more markets.
When should it be used?
When establishing a risk management system, when remediating a risk file against ISO 14971:2019 clause requirements, or when preparing the risk documentation an FDA investigator, Notified Body, or MDSAP auditor will review.
What does it include?
- Risk Management Procedure (SOP), mapped to applicable regulatory frameworks
- Risk Management Plan template, built to ISO 14971:2019 Clause 4.4
- Risk Evaluation and Acceptability Matrix, with severity and probability scales and evaluation flow
- Design and Process FMEA templates, with a Change Risk Assessment form and flow
- Residual Risk and Risk Management Review forms (Clauses 7 to 9)
Version: Aligned to ISO 14971:2019 and FDA QMSR effective February 2, 2026
Free to use. Tell us where to send it and the download links will appear.
Need more than a template?
SA Quality Solutions provides implementation support, gap assessments, internal audits, and remediation services for FDA QMSR, ISO 13485, MDSAP, and EU MDR. If you would rather have this done with you than do it yourself, a 30-minute discovery call is available at no cost.
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Risk Management Services · Technical Documentation Review · QMS Remediation