DHF - Design History File/Technical File Remediation for Ophthalmic Products | HCL Technologies

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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.