Technical files

All medical devices must have a technical file; regardless of whether it is a simple Class I or a complex Class III product. The structure of the technical file is not controlled by the regulations, but the file must contain a number of critical elements.

Too often we see companies who are closing in on the launch of a product, a launch which sometimes will determine the future of the company, only to realize that they do not have their technical file in order. We can help you sort out situations like this in an efficient and methodical manner.

More often, we encounter companies where a medical device has been launched a few years earlier, but the information in the technical file has not been updated. Perhaps it is time for the Medical Products Agency or the Notified Body to perform an audit, including an inspection of the technical file. Have the changes in MDD from March 2010 been considered? What impact do these changes have on your product? In situations like this, Symbioteq can offer you the support you need. We will provide you with the support and advice to guide you through the process of setting up and review your technical file. With our help, our clients continue to succeed in their businesses ventures.