ISO 14971 Medical Device Risk Management Full Compliance Kit
The complete ISO 14971:2019 risk management file toolkit. 21 professionally written templates covering every phase of the risk management process.
Risk Management Plan
Template document
Risk Management Process Description
Template document
What's included
Everything you need to build a complete compliance documentation set.
- Risk Management Plan
- Risk Management Process Description
- Risk Analysis Report
- Hazard Log
- Intended Use and Foreseeable Misuse Record
- Device Safety Characteristics Document
- Failure Mode and Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Risk Evaluation Report
- Risk Control Option Analysis
- Risk Control Implementation
- Risk Control Verification
- Traceability Matrix
- Residual Risk Evaluation
- Benefit-Risk Analysis
- Overall Residual Risk Evaluation
- Production and Post-Production Plan
- Post-Market Risk Review
- Risk-Related CAPA
- Risk Management Review Report
- Risk Management Report
Is this right for you?
We believe in being upfront. Here's who this pack works best for.
- Manufacturers building a complete ISO 14971:2019 risk management file
- Teams needing structured analysis methods (FMEA, FTA) alongside core documents
- QA/RA functions preparing for NB review or FDA pre-submission with a full risk file
- Organizations integrating risk management with IEC 62304, IEC 62366-1, and ISO 13485
- Organizations only needing mandatory risk management documentation
- Teams with simple products not requiring FMEA/FTA analysis
- 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.