Minimise your business risk and comply from day one!
You, the medtech DEVELOPER!
Regulatory compliance is one of the foundations of a successful business. It must be built into your product development from day one, but mastering the hundreds of pages of complex regulations is an art and consumes too much of your time. Take our digital tool, Entries, for a minute runway towards CE marking and global market access of your medical device!
You, the medtech INVESTOR!
Today, too many medtech development initiatives fail slow. The regulatory hurdles tend to grow substantially if not tackled from day one. We carry out regulatory due diligence and training as a win-win for you and the developer. Give us a call and let us explain you how compliance is turned into a competitive advantage of your portfolio companies!
You, the medtech REGULATORY PROFESSIONAL!
Embrace Entries as a tool for lean exploration of the regulatory essentials. Take the runways together with your business leads, developers and suppliers to educate them in an instant and accelerate your time to market. Follow us as we speak on the regulatory essentials internationally and come meet us face to face!
How Does It Work?
Complex medical device regulations in a simple flowDigital Start towards CE-marking
Entries takes you through the questions necessary to determine if your product is regulated as a medical device or an in vitro diagnostic (IVD) device according to the MDR or the IVDR, and if so, what is the risk class of the device. The service then guides you further into other regulatory essentials based on your medical device classification and type.
Minute Runways
Finding and interpreting this information would traditionally take anything from hours of flipping through the piles of regulations, to months of not knowing where to look and risking the viable direction of a product development project. Entries puts you on a minute runway and a steep learning curve towards compliance, best practices and a solid foundation for your business.
Complete Report at the End
Entries is regulatory contents turned into a flow. It provides clause by clause references and links to the original requirements throughout the runways. It presents the terminology, examples and guidance from the regulatory sources in an intuitive format and generates a Final Report, with complete references, as a rationale for you to dive into the development of your product.
Take the Regulatory Runways into
EU Medical Device Directives
New EU Medical Device Regulations
Need more advice, training or hands-on help with compliance and global market access?
Get in touch with us for the
Regulatory Support Pack
Happy clients!
You’re contributing in depth and highly valuable knowledge in a very user friendly way to the startups in Health Tech 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.
Neuro Event Labs, a member of Health HUB
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