Lean Entries is dedicated to reduce substantially the time spent by organizations on regulatory compliance, starting from the heavily regulated Medical Device industry. We want to let organizations focus on their core activities and see a growing number of medical innovations break through to the market.
The first regulatory runways on the Entries platform guide any medtech stakeholder through the questions necessary to determine, if their innovation is regulated as a medical device or in vitro diagnostic (IVD) device, and if so, what risk class. The services support the current European medical device directives and the new regulations, the MDR and the IVDR.
This information is vital for the innovators from day one on their pursuit towards CE-marking and global market clearances, and at every iteration of their tech and its intended use. We have reorganized the hefty bit of documentation related to this task into minute runways that provide clause by clause references and links to the original documents and a full rationale at the end of the path.
The Entries platform bears a unique logic developed by Lean Entries that allows complex information, such as regulations, standards, policies, processes and manuals, to be re-organized into minute digital runways. Entries is made available as a white label solution for organizations who seek significant savings and competitive advantage from streamlining such complexities for their internal or their clients' use. This development of Entries is supported by the Leverage from the EU 2014-2020 program of the European Regional Development Fund.