I definitely agree with your response alexandrabuga. From a global standpoint, both 21 CFR 820 and ISO 13485 are guidelines for medical device companies to use for not only documenting, but ensuring procedures for controlling quality are in place and the medical device or in-vitro diagnostic (IVD) are complaint with regulations. With the use of electronic repositories for the Design History Files (DHF), it has become a lot more intuitive and easier to manage documenting design controls. I work for a medical device company, and our DHF repository is a customize system to ensure users are trained, have the appropriate permissions, versioning of documents is controlled, requires selection of the DHF and non-DHF as well as the category of the design control (planning, input, output, review, transfer), and manages the approval process for reviews and signatures on documentation during each phase of the product development. It is a continuously validated system, in which is approved and reviewed by quality either when necessary or bi-annually.

There are new EU regulations that are anticipated to go into effect for medical device regulations (MDR) by 2020 and IVD regulations (IVDR) by 2022. These regulations are to improve the quality, safety, and reliability of medical products. For more information, please use the link below.

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#new_regulations