Risk management in accordance with ISO 14971 is critical for any medical device. It is important for the company to have a comprehensive risk management plan in place and to ensure that risk mitigation activities take place early within the medical device design process. Qualitas can provide risk management activities and plans that meet the requirements of ISO 14971. FDA requires an independent reviewer to participate with the risk management reviews and Qualitas can act as this. We can help you through every step of the risk management process and will work side-by-side with you to streamline this process and help you achieve compliance.
Helpful Links: FDA and Medical Device Industry