ISO 14971
ISO 14971 is an international standard that provides a framework for risk management in the design, development, and production of medical devices. It outlines a systematic process for identifying hazards, estimating and evaluating risks, controlling risks, and monitoring the effectiveness of controls throughout the device lifecycle. The standard is essential for ensuring patient safety and regulatory compliance in the medical technology industry.
Developers should learn ISO 14971 when working on medical device software or hardware to meet regulatory requirements such as those from the FDA (U.S.) or EU MDR, and to implement safety-by-design principles. It is used in scenarios like developing diagnostic equipment, implantable devices, or health monitoring apps to systematically address potential harms and document risk management activities for audits and approvals.