MCRA experts can you show how to properly create and maintain DHF to ensure a more efficient quality assurance down the line.
Services We Offer
- Design History File (DHF) reviews and remediation
- Implementation of design control process
- Facilitation of design review meetings
Our Integrated Approach
The FDA requires proof of compliance with established design control procedures during the product design and development phase. Medical device manufacturers need to maintain records known as Design History Files (DHF) documenting compliance with established design control procedures, and have them ready for regulatory inspection once they obtain market authorization for their medical device. MCRA’s experts can show you how to properly create and maintain DHF to ensure a more efficient quality assurance down the line.
