ISO 14971 Medical Device Risk Management Mandatory Documents Kit
ISO 14971:2019 is the international standard for risk management of medical devices and is mandatory for CE marking under EU MDR. This kit contains the 12 core documents needed.
Risk Management Plan
Template document
Risk Management Report
Template document
What's included
Everything you need to build a complete compliance documentation set.
- Risk Management Plan
- Risk Management Report
- Hazard Log and Hazard Identification Worksheet
- Risk Estimation and Evaluation Worksheet
- Risk Acceptability Criteria Definition
- Risk Control Options Analysis
- Risk Control Implementation Record
- Risk Control Verification Record
- Residual Risk Evaluation Summary
- Benefit-Risk Analysis
- Overall Residual Risk Acceptability Statement
- Post-Production Information Collection and Monitoring Procedure
Is this right for you?
We believe in being upfront. Here's who this pack works best for.
- Medical device manufacturers integrating ISO 14971 into a QMS under ISO 13485 or EU MDR
- Risk managers and QA engineers responsible for device risk documentation
- Teams building or updating their risk management file for technical file or 510(k) submission
- Startups developing medical devices needing a structured risk process from day one
- Organizations already certified with complete risk management documentation
- Teams needing FMEA/FTA analysis methods
- Those unfamiliar with ISO 14971 requirements
Why teams choose this pack
Practical benefits without the hype. Here is what you actually get.
Clarity from the start
No more staring at blank documents. Each template shows you what belongs where and why it matters.
Hours saved on structure
Skip the research phase. Start with proven layouts that align with regulatory expectations.
A path to follow
The included guides give you a practical sequence so you know what to tackle first.
Foundation to build on
These templates grow with you. Adapt them as your compliance program matures.
Questions about this product
Common questions specific to this template kit.
Ready to get started?
Skip the blank-page anxiety. Start with structure that aligns with ISO 14971 and adapt it to your context.
Instant download. Free updates. Single organization license.