Before exploiting these regulatory tools I was daunted by the complexity of regulatory compliance.
The Entries tool is very effective in transmitting knowledge. I have experienced nothing comparable to it as an educational hands-on application. I've certainly saved weeks worth of my time in reaching this new level of regulatory knowledge and find confidence in moving forward.
Urisens project, Aalto University & SPARK Finland
The process has a very value-creating hands-on format, which forces us to have a critical view of our product and concept.
We are really pleased with your digital service, the Entries. It's easy and intuitive to use and has helped us a lot. 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.
Lean Entries holds fine means to transmit a massive amount of challenging information for the startups and researcher teams in our region. The digital Entries platform and webinars they provide enable an efficient formation of common language and basic know-how on the medical device regulations.
The concept was valued high due to its clear benefits gained en route to the international market.
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 realized that compliance is nothing separate from our marketing and business efforts, but everything we do for the sake of compliance, starting from risk management and clinical evaluation, translates into smart and efficient business and highly valuable marketing material.
Their digital service [Entries] encompasses a lot of that early stage wisdom, so we say - go indulge yourselves!
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. "I know kung-fu!" kind of an experience, as Neo put it.
With the combination of services from Lean Entries, we were delighted to have a speedy start. Now, when our Causalus application is CE-marked, we appreciate even more how the seemingly complex regulations and standards were presented in the most simple and usable format. It was easy to dive into the details and focus on the pain points when the basics were clear and made sense. Without a doubt, gaining this knowledge efficiently, we were able to avoid the typical roadblocks and the savings in our time were counted in months.
By using Entries, we were able to qualify and 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.
Neuro Event Labs, a member of Health HUB
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 digital service Entries for some months. The platform has helped us to assess and cross check the classification of various medical devices. It has been a useful source to support our daily business and saved us time and – as a result – money