ISO 14971 is the international standard that defines how to identify, evaluate and control risk across the entire lifecycle of a medical device. We help you build a risk management process that is practical, defensible and ready for audit.
ISO 14971 sets out a systematic process for risk management throughout the lifecycle of a medical device. It is referenced in virtually every regulatory framework worldwide and forms the foundation of a defensible safety argument.
Risk management under ISO 14971 is not a one-off activity. It runs from concept through development, into production, and continues with post-market surveillance, feeding back into your design and processes.
Whether you are setting up your risk management process from scratch or updating a legacy file, we work with you end to end.
We draft a plan that fits the size and complexity of your device, your team, and your target markets.
Facilitated sessions with your team to systematically identify hazards, hazardous situations and harms.
We build or review your risk management file, including FMEA, fault tree, or hazard tables as appropriate.
We integrate PMS, PMCF and complaint data back into your risk file, closing the lifecycle loop.
A defensible benefit-risk justification for residual risks, aligned with MDR, FDA and ISO 14971:2019 expectations.
In-house training or 1:1 coaching for your R&D, RA and QA teams. Practical, example-driven, RBP certified.
FAQ
ISO 14971 itself is not law, but conformance to it is the recognised way to meet risk management requirements in virtually every market. EU MDR, FDA, TGA, Medsafe, MHRA and most Asian regulators expect a process aligned with ISO 14971. FMEA is a tool. ISO 14971 is a framework. You can use FMEA, fault tree analysis or hazard tables inside an ISO 14971 process. The standard is method-neutral, what matters is that risks are systematically identified, evaluated and controlled. ISO 13485 requires you to have a risk management process. ISO 14971 tells you what that process should look like for medical devices. The two work hand in hand: your QMS owns the process, your risk file owns the evidence.
The A11 amendment adapts ISO 14971 for use in the EU under MDR and IVDR. It clarifies how the standard supports the General Safety and Performance Requirements. If you sell in the EU, this is the version you align to.