Select Page
nonconforming materials report

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.  

Get your FREE White Paper here!

* These fields are required.