Dr.Simon mentioned (in Week 3) about DHF, Design History File is required by law in 21CRF820.3(e) – “a compilation of records which describes the design history of a device”. Also, the DHF should contain some basic documents:
PDF, DDP, DID
– Business plan, market research
– Risk Analysis
– Research protocols: clinical and pre-clin
– Regulatory pathway
The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.Your DHF must be accurate and should be a “living” document, meaning it should be consistently updated even beyond the development phase. When you archive your DHF after manufacturing, it defeats the purpose. It should always be an accurate representation of the product you are delivering.Design History File (DHF)–> Inputs to –> Device Master Record (DMR) –> Inputs to Device History Record (DHR)