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.
Juha Vaaraniemi, Director, Design and Advisory Services