This comprehensive white paper can be helpful for medical device companies to strategically update their risk management process to not only satisfy the requirements of the 3rd Edition of the ISO 14971 standard, but to improve their risk management process.
This whitepaper helps you about the expectations of the 3rd Edition standard in perspective and provide ‘framework’ suggestions as to how your organization should proceed with updating your risk management program to meet the intent of the updated standard. The mission of the FDA CDRH is to “protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.