Medical Device Qualification and Classification by

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The service is surely a great help for a company like Innokas Medical, as we work in close collaboration with our clients to help them to design, develop and manufacture regulated medical devices. One still needs to interpret the information from the point of view of the intended use of a specific device, of course, but it does help a lot to have a tool where this information is structured into a path.

- Tiina Kotipalo, Head of QA/RA, Innokas Medical


We have been using Lean Entries’ service for about six months. The platform helped us to assess and cross check the classification of various medical devices. It was a useful source to support our daily business and saved us time and – as a result – money.

- Michael Sander, VP Sales & Marketing and Martina Sander-Giesemann, VP Operations, mdi Europa GmbH