Risk management is a systematic approach to identifying, assessing, and mitigating potential risks associated with medical devices. With patient and operator safety being a top concern in the medical device industry, it is crucial for innovators to ensure that their products are reliable and safe to use. Regulators developed ISO 14971 to provide guidance on the application of risk management to medical devices.
This international standard is a powerful tool for manufacturing safer and higher-quality medical devices that lays out the requirements and principles for managing risks. It provides a framework for manufacturers to implement a consistent, thorough, and effective risk management process. It is essential for medtech developers to understand ISO 14971, as it provides a common language for risk management, ensuring consistency and clarity in the industry.
While compliance with ISO 14971 is mandatory, it does offer numerous benefits to medtech developers. Manufacturers can enhance the safety and quality of their products, leading to improved patient outcomes and reduced adverse events. ISO 14971 also helps medtech developers to identify and evaluate potential risks early in the development process so that appropriate risk control measures can be implemented. Taking a proactive approach minimizes the likelihood of incidents and recalls, protecting both patients and operators.