Medical Device File

Medical device file is a set of documents that describe a product and can prove that the product was designed and manufactured in accordance with ISO 13485 requirements and other applicable requirements. On the European market, all medical devices must have the Technical file under 93/42/EEC of the Medical Devices Directive (MDD). This technical file is in accordance with the medical device file. On the US market, medical devices must have a Desing master record according to the FDA, which also matches the medical device file. So for guidelines on how to prepare a medical device file, please search in the mentioned regulations.

For more information on ISO 13485:2016 requirements for medical device files, please read the following article: 

ISO 13485:2016 requirements for medical device files https://advisera.com/13485academy/blog/2017/06/28/how-to-meet-iso-13485-requirements-for-medical-device-files/