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.
The process has a very value-creating hands-on format, which forces us to have a critical view of our product and concept.
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.
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.
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.