Design History Files – Design Control Documentation

Your organization has identified a new product idea for a medical device.  What’s next?  This White Paper focuses on Design Control compliance for Medical Devices per 21 CFR 820.30 and ISO 13485: 2016 § 7.3, including Design History File documentation. The DHF is a compilation of records which describes the design history of a finished device.  It includes or references records generated to demonstrate conformity to the requirements for design and development, as well as records for design and development changes.