Quality Magazine recently published an article “A Risk Based Approach For Medical Device Quality Management” written by Anne Holland, CEO and Founder of QA Consulting, Inc. The team at QA Consulting has provided personalized consulting services for early stage, mid-size and Fortune 500 medical device companies for over 15 years.
ISO 13485:2016 Medical devices — Quality management system — Requirements for regulatory purposes, has an increased focus on managing risk. No longer is risk management designated for design and development. A risk based approach is now required to be implemented throughout the Quality Management System (QMS) processes.
Download the article here to understand four (4) strategies for implementation of a comprehensive, effective and compliant risk based QMS.