From this lecture we have learned how to prepare our first DHF file, and as Dr.Simon mentioned about 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.

So,(according your work experience), tell us about your ideas to ensure your DHF is audit ready ?

For example:
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.