Developing a Design History File: From Inspiration to Reality

The process of developing a new product is an exciting one. Being caught up in the innovation bubble, however, can potentially lead to compliance falling further down the priority list.

The importance of a robust Design and Development procedure cannot be underestimated. European regulatory authorities require some sort of design history, and it does not have to be a hugely cumbersome document or technical article, nor should it be an epic piece of prose.

This whitepaper provides a practical guide on the key benefits and processes medical device companies should consider for the implementation of an effective Design and Development procedure that adds value to business operations and meets regulatory needs.