Risk Management

Risk Management — ISO 14971

We help medical device companies build and maintain comprehensive risk management programs that satisfy the requirements of ISO 14971 — the internationally recognized standard for risk management applied to medical devices.

What We Offer

• Risk Management Planning — We develop risk management plans tailored to your device, defining scope, responsibilities, risk acceptability criteria, and the overall risk management process for your product lifecycle.
• Hazard Identification & Risk Analysis — We facilitate structured risk analysis activities — including FMEA, FTA, and preliminary hazard analysis — to systematically identify hazards, hazardous situations, and sequences of events that could lead to harm.
• Risk Evaluation & Estimation — We help you estimate and evaluate risks using your defined criteria, ensuring decisions are documented, defensible, and aligned with state-of-the-art expectations.
• Risk Control Implementation — We guide the selection and documentation of risk control measures in accordance with the ISO 14971 hierarchy, and verify their effectiveness through testing and analysis.
• Residual Risk & Benefit-Risk Analysis — We support the evaluation of residual risks, overall residual risk acceptability, and benefit-risk determinations required for regulatory submissions and design files.
• Risk Management File Development — We compile and organize your risk management file to ensure it is complete, traceable, and audit-ready for FDA, Notified Bodies, and other regulatory authorities.
• Post-Market Surveillance Integration — We connect your risk management process to post-market activities, ensuring real-world data feeds back into your risk file and supports ongoing lifecycle risk reviews.

Why It Matters

ISO 14971 compliance is a prerequisite for CE marking under EU MDR, FDA 510(k) and PMA submissions, and global market access. Regulators expect risk management to be proactive, systematic, and woven throughout the entire product lifecycle — not treated as a one-time checkbox. A strong risk management program protects patients, reduces liability, and accelerates regulatory approval.

Who We Serve

We work with medical device manufacturers, startups, and contract development organizations across all device classifications — from concept and design through post-market surveillance and product updates.