At Lean Entries we are dedicated to reduce the time spent by organizations on regulatory compliance. Our focus and deepest knowledge lies in the heavily regulated Medical Device industry. For this, Lean Entries has provided an easy tool for medical device qualification and classification. We want to let organizations focus on their core activities and, as a result, see number of medical innovations break through to the market.
The first regulatory runways, on the Entries platform, guide any medtech stakeholder through a line of questions. The answers given will determine if the innovation is regulated as a medical device or as a vitro diagnostic (IVD) device. Also, the runways determine the risk class of your device. The services support the current European medical device directives and the new regulations, the MDR and the IVDR.
When pursuing CE-marking and global market clearences for your device this information is vital from day one. We have reorganized the hefty bit of documentation related to this task into minute runways. The runways provide clause by clause references and links to the original documents and a full rationale at the end of the path. Lean Entries will not just save you time and money but increase your know-how.
The Entries platform
The Entries platform bears a unique logic developed by Lean Entries. The platform 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.