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MDR documentation: secure and easy with QuDoc
01.03.2021
QuDoc, the secure data management system from tuomi, meets all the requirements of the MDR and GDPR. It is the perfect tool for managing documentation in accordance with the Medical Devices Regulation.
Documentation is key when it comes to Medical Device Regulation. And of course, there are certain requirements that have to be fulfilled:
- Not all documents must be available to everyone, however:
- Documents must be available to everyone who is affected,
- Documents have to be readable for some persons and editable for others,
- Data has to be stored encrypted,
- Any software used to store documentation has to be validated.
Our filesharing software QuDoc is a validated data sharing and data storage platform that matches all the requirements above. QuDoc offers you a convenient way to share information internally and – if necessary – externally. Our system was developed according to the highest data encryption standards.
Usability and security combined
QuDoc does not require additional software since it is browser-based for easy access and usability. All aspects of the EU GDPR and MDR are implemented. It is therefore perfectly fitted for your documentation measures according to MDR and Quality management system norms such as ISO 13485:2016.
Additionally, it runs on EU-located servers and supports versioning of files – an important tool to keep your records up-to-date while also keeping track of changes. You can start right away with our easy-to-use solution: Contact us at mail@tuomi.de.