Lean Entries Ltd was found and hired by OuluHealth due to their intuitive digital solution (Entries) to solve the early stage regulatory challenge and their mission to empower health tech startups. In their trainings, they make the complex regulatory topic resonate with competitive gains and modern business practice. Their one-on-one regulatory clinics have put our community startups and innovators on an informed track towards compliance. As a result, the investment made by OuluHealth has already paid back after one month into the program that spans a full year. ...
You’re contributing in depth and highly valuable knowledge in a very user friendly way to the startups in HealthTech Nordic.
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!
Thanks to Lean Entries and their mastery on regulations and standards, we are now an ISO 13485 certified software provider and have released our first CE-marked medical device software. We remain a happy camper on Entries, their digital service grounds, which helps us with communicating compliance to our co-operators and evaluating the regulatory status of new software in our pipeline. Entries is a great leap from analogue to digital in sharing such complicated information. ...
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 digital service (Entries) 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 the Lean Entries’ digital service Entries 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
With the upcoming radical changes by the EU MDR, as the leading importer and distributor of ophthalmic surgical devices, we saw it absolutely necessary to have a third party see through our liabilities, internal processes, and also verify that our global suppliers are doing their part.
The regulatory experts of Lean Entries made the whole process streamlined and transparent, providing us a clear roadmap for future improvements, and highlighting areas of potential business risk.
The added value was not just proper corporate governance, or peace of mind, but of direct benefit to our bottom line.