Thank you for a great workshop on the regulatory essentials for us, the Nordic Health Tech Talents of Venture Cup Denmark! We are really pleased with your digital service, the Entries, to classify our medical device. It's easy and intuitive to use and helps a lot with discussing all possible classification rules that may apply to a medical device. We definitely recommend Entries and your trainings for other health tech startups and innovator communities!
You’re contributing in depth and highly valuable knowledge in a very user friendly way to the startups in HealthTech Nordic.
We used Lean Entries' expertise on regulations early on before typing a single row of code and establishing Noona Healthcare as a company to help cancer patients. We still tap ourselves on the back for being smart enough to ask someone who knows the medical device regulations. The insight and advice we received during just one day made sure we want to write compliance into our company's DNA...
By using Entries, we were able to classify our device in only a moment and print out a fully referenced rationale for our records and for discussions with the authorities. We give credit to the intuitive service concept and hope this is only the beginning of a series.
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.
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