who we are
Lean Entries is dedicated to reduce substantially the time spent by organizations on regulatory compliance. We want to see organizations focus on their core activities by helping them reach basic compliance within a few days, starting from the heavily regulated Medical Device industry.
Our first digital services allow any Medtech stakeholder make a quick assessment, whether their product qualifies as a medical device and what is the risk classification of that device according to both, the current medical device directives and the new regulations. We will develop the platform further with our Partners to contain many other digital services for regulatory compliance.
The benefits of our digital walk-throughs are convenience, speed, contextual learning and simultaneous accomplishing of necessary tasks hands-on. Global regulations and standards in the medical device industry are vast and various. We aim to cut this burden into half for the startups. For the regulatory experts, the platform offers an opportunity to scale their know-how and services on a global level.
what we are looking for
We welcome contacts of all kinds from the medtech industry and from potential partners in other industries. We can reach our vision only through intense cooperation with various parties and the platform is intended to be exploited by the many regulatory experts and stakeholders globally.
We, the founders of Lean Entries, Ltd., are a team of five with years of experience from entrepreneurship, design and development, quality management, regulatory affairs, distribution and sales, and clinical work with medical devices. In addition, our CEO, Heikki Pitkänen, has five years of experience as a team leader in a Notified Body and accredited certification bodies. He is a member of the CEN-CENELEC Advisory Board for Healthcare Standards.