Risk Management — ISO 14971, FMEA & Benefit-Risk
Under EU MDR and FDA expectations, risk management is not a document — it is the thread that ties design decisions, clinical evidence, and post-market data together. Auditors increasingly test that thread: pick a hazard, and trace it to a control, a verification, and a residual risk judgment.
Confiquora builds ISO 14971:2019 risk management systems that survive that trace: complete risk management files, design and process FMEAs that engineers actually use, defensible benefit-risk determinations, and surveillance loops that feed real field data back into the file.
What you get
- Complete ISO 14971 risk file
- Design & process FMEAs
- Benefit-risk determinations
- Live post-market risk surveillance
Standards & frameworks we work in
How an engagement runs
Discovery → Gap Assessment → Strategy → Implementation → Certification → Ongoing Support. Every engagement follows the same spine — scoped in the first call, priced before we start, and handed over with your team trained to run what we build.
Frequently asked questions
Is FMEA enough to satisfy ISO 14971?
No — FMEA is one analysis tool, not a risk management system. ISO 14971 requires an end-to-end process: planning, hazard identification, evaluation, controls, residual risk, benefit-risk, and production/post-production feedback. We build all of it, with FMEA in its proper place.
How does risk management connect to the technical file?
The risk management file is a core technical file component and must align with the clinical evaluation, usability file, and GSPR checklist. We keep those cross-references consistent — misalignment between them is a classic notified body finding.
Do you run risk management workshops with our engineers?
Yes — facilitated hazard analysis and FMEA sessions are usually the fastest way to both build the file and transfer the skill.
Talk it through with us
Free 30-minute consultation. No obligation — just a clear read on where you stand and what it takes.
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