Design History File/Technical File (DHF) is a compilation of records which describes the design and development history of a finished medical device or medical product. A Design History File is a formal document that is prepared for each medical device. The Design History File/Technical File can be either a collection of the actual documents generated in the product development (PD) process or an index of documents and their storage location.
This Whitepaper focuses on the right Design History File/Technical File remediation approach, needed to be followed to identify the gaps in the documents and different phases of Design History File/Technical File for Ophthalmic products and devices as per ISO 13485:2016.