ISO 14971 compliance checklist

ISO 14971 lays out the core risk management considerations for a medical device organization. It is not an auditable standard which you can get accreditation for, nor is it mandatory to bring your medical device to market. Nevertheless, ISO 14971 offers a useful, comprehensive and industry trusted framework for embedding GMP into your organization and properly managing the risks connected to your medical device design, development and manufacture. Use this checklist to ensure you meet and apply the demands of the standard.