We help medical device manufacturers build a compliant ISO 14971 risk management process and file — integrated with your ISO 13485 quality system and design controls.
Book a consultation All servicesISO 14971 is the international standard for the application of risk management to medical devices. It defines a lifecycle process — risk analysis, evaluation, control, and residual-risk assessment — that runs from concept through post-market surveillance.
Regulators expect it: the FDA recognizes ISO 14971, and the EU MDR and IVDR effectively require a conforming risk management process. Done well, it's not paperwork — it's the backbone that connects your design controls, verification, and post-market feedback.
We build the risk management plan and a well-organized risk management file that tells a clear, auditable story from hazards to residual risk.
We run structured hazard analysis and design/process FMEAs that tie real failure modes to real controls.
We document risk-control verification and a defensible overall benefit-risk conclusion that stands up to notified-body and FDA scrutiny.
We connect risk management to your QMS, design controls, and post-market surveillance so everything reconciles.
ISO 13485 is your medical device quality management system; ISO 14971 is the risk management process that lives inside it and feeds your design controls. Auditors expect the two to reconcile — we make sure they do.
The FDA recognizes ISO 14971, and the EU MDR/IVDR effectively require a conforming risk management process. In practice, you cannot clear or CE-mark a device without it.
No. An FMEA is a useful tool, but ISO 14971 is the overarching risk management process — including benefit-risk analysis and residual-risk evaluation that a standalone FMEA does not cover.
Yes. We right-size the risk management system to your device and stage so it satisfies regulators without drowning a small team in documentation.
Led by a quality executive with 15+ years across diagnostics and medical devices — we build ISO 14971 risk management that regulators and notified bodies accept.
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