Lean Entries is dedicated to reduce substantially the time spent by organisations on regulatory compliance, starting from the heavily regulated Medical Device industry. We want to see organisations focus on their core activities by helping them reach basic compliance within hours and days instead of weeks and months.
Our service concept is based on digital runways that bring convenience, speed and contextual learning into play for achieving the needed compliance, hands on. By this concept, we aim to cut the regulatory burden into half for the startups, and bring serious relief to experienced regulatory teams across the globe.
The first digital runways on our platform allow any medtech stakeholder make a quick assessment, whether their product qualifies as a medical device, an in vitro diagnostic (IVD) device, or an accessory to either one, and what is the risk class of that device according to both, the current European medical device directives and the new regulations: the MDR and the IVDR. This is the first step into CE-marking any medical devices.
We are developing the platform further with our Partners to offer many more digital runways into compliance, and to host a library of global regulations and compliance services relevant to each topic. We want to see a growing number of medical innovations break through to the market.