RA
RISK ASSESSMENT
We offer specialized risk assessment services to help companies—especially those in the medical equipment sector—identify, evaluate, and control potential hazards throughout the product lifecycle. Our team conducts thorough risk analyses in line with ISO 14971 and applicable regulatory requirements, covering design, manufacturing, and post-market activities. We provide detailed risk management plans, risk-benefit evaluations, and mitigation strategies to ensure your products meet safety and compliance standards while supporting clinical and regulatory submissions. By integrating risk management into your processes, we help you minimize liability, enhance patient safety, and maintain regulatory readiness.
ISO 13485
This book provides a clear and practical explanation of ISO 13485 with a strong focus on risk assessment as a core element of an effective medical device quality management system. It guides readers through the identification, analysis, evaluation, and control of risks across processes, products, and regulatory requirements, aligning risk-based thinking with real-world application. The content translates complex clauses into understandable, actionable steps, helping organizations integrate risk assessment into daily operations, decision-making, and continual improvement while maintaining compliance with international medical device regulations.
ISO 13485
Risk Assessment