With Lean Entries and their unique service concept, a combination of webinars and Entries, the digital fast-track tool into the medical device regulations, we give the local innovators a chance to excel in regulatory compliance early on and turn it into their competitive advantage.
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. ...
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. ...
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. ...
Minimise your business risk and comply from day one!
You, the health tech DEVELOPER!
Regulatory compliance is one of the foundations of a successful business. It must be built into your processes and product development from day one, but mastering the hundreds of pages of complex regulations and standards is an art and consumes your time. Take our digital tool, ENTRIES, for a minute runway towards CE marking and utilise our regulatory services to gain the global market access for your medical device!
You, the health tech INCUBATOR!
Whether you’re an innovation lab, university, accelerator or the like, you aim to generate success stories. The combination of ENTRIES, our digital regulatory runways, with training on regulatory essentials and one-on-one sessions with your innovators puts them on a steep learning curve to turn regulatory compliance into their business advantage. Study our testimonials. Your investment pays back many times over!