Improving Medical Device Risk Management

Medical device product development has historically served as a cornerstone of medical progress, dating back to the earliest attempts to heal people. The management of risks associated with medical devices necessitates a foundation built on dynamic design elements.

This process is integral to the highly integrated and regulated nature of medical device product development, with two critical standards:

• The International Organization for Standardization
• ISO Technical Information Report

This whitepaper has been authored, presenting a comprehensive repository and workflow management solution tailored to the specific needs of medical device development.