Lean Entries Ltd. is a group of regulatory compliance professionals with decades worth of know-how from the medical device sector. The company started in 2016 with a mission to light the way into compliance for every health tech developer around the world. We’ve been working in startups, large multinational companies, accredited test labs and Notified Bodies. The Entries platform was born for turning the piles of regulatory requirements into minutes of clarity and instant actionable knowledge for the health tech developers. Accomplishing our mission means, that the developers will be far better equipped to face the remaining regulatory challenges and have an increased chance to evolve into viable medical device manufacturers. As a result we will see a growing number of life altering medical innovations break through to the market.
Since 2021 we are part of Labquality. Please see Labquality’s announcement on the acquisition from 8 Feb 2021.
We’re an active member of Healthtech Finland and their regulatory affairs working groups, Upgraded, the Health Startup Association of Finland and HealthHub. We contribute to CEN-CENELEC and their Advisory Board of Healthcare Standards (ABHS), as well as to the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) as a member of the Finnish healthcare standardisation.