Hoodin has fulfilled all the requirements as software included in the scope of Post Market Surveillance in medical technology.
DigiLab of Metecon GmbH has hereby certified that the software of Hoodin meets industry-specific quality standards for software for Post Market Surveillance for the medical device industry.
What is DigiLab?
DigiLab connects regulatory affairs processes with the right software tools. Metecon-DigiLab is a bidirectional service platform that connects the providers of suitable software solutions with the manufacturers of medical devices and IVD. The expertise of the DigiLab team and their preparatory work create essential added value for both sides - manufacturer and software provider.
DigiLab is a project of Metecon GmbH. This allows them to draw on their know-how and experience of more than 50 experts in all areas of regulatory compliance. In the past 20 years they have successfully completed more than 500 projects related to the documentation, market access and market monitoring of medical devices and IVD.
Since 2019 they have been working intensively on the possibilities, techniques and processes of process digitization on behalf of their customers.
DigiLab qualification criteria to verify the quality standards:
The software meets the basic industry-specific requirements for international regulatory processes.
The software is capable of achieving compliance with existing laws and standards.
The associated functionality has been objectively tested by DigiLab.
The software is part of DigiLab: a collection of software that DigiLab rates as very high quality solutions for Regulatory Affairs due to their functionality, usability and technical standard.
Hoodin has fulfilled all the requirements included in the scope of this evaluation.
This certificate is valid exclusively for the tested software at the time of testing and entitles the holder to use the depicted DigiLab test mark for advertising purposes during the validity period of this certificate as a non-transferable right.
Metecon DigiLab is an independent consultant and service provider for the digitization of all regulatory processes for manufacturers of medical devices and in-vitro diagnostics. In doing so, Metecon GmbH draws on more than 20 years of experience as a complete service provider for regulatory market access.
Certificate number: 2022-012
Qualification criteria: https://metecon-digilab.de/en/qualifizierungskriterien-software/