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Lean Entries: Regulatory Compliance Services for Health Tech Ecosystems

23rd June 2020

Regulatory compliance can be tough. Many health tech startups have failed due to the sheer complexity of medical device regulations.

This is where we come in; We’ve seen regulatory compliance and non-compliance from many perspectives, working in startups, large multinational companies, accredited test labs, Notified Bodies and as consultants. We’ve gained a load of experience from the field and enjoy giving our know-how back to those, who can make great improvements in healthcare but need support with regulations and standards. 

Our job is to open up the size of the missed opportunities. After which, we can focus on the added value our service concept brings to health tech ecosystems and individual companies; Regulatory knowledge transferred into runways to put companies hands-on with compliance from Day One!

The spearhead of our services is the Entries platform, where months worth of studying the regulations have been turned into minutes of intuition to speed up CE marking of medical devices. We combine Entries, our digital regulatory runways, with webinars on the regulatory essentials and one-on-one sessions with the startups and innovators in the ecosystem. We help them to the point that regulatory compliance is no longer a hindrance, but a business advantage that saves them months worth of time en route to the global healthcare market.

Lean Entries was featured in a Business Tampere video blog. The blog explains our position in the startup ecosystem and how we help to turn local health tech businesses into success stories. 

We have recently partnered up with Business Tampere, Tampere University and SPARK Finland to organise the webinar series on Regulatory Essentials in Health Tech for local innovators and startups and grant them access to the Entries platform. This concept provides the Tampere Health Technology and Life Sciences Ecosystem innovators a kick-start into regulatory compliance.

Find out more about the webinar series.

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Posted by Heikki Pitkänen

Heikki Pitkänen
Heikki is backed up with 20 years of experience from the Medical Device industry, most recently from certification bodies, and is active in international standardization. He is passionate with the modern startup, business model and service design concepts and believes in co-operation between knowledgeable parties for reaching great achievements.
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