Lean Entries Blog

Youtube Series on Regulatory Essentials

14th October 2020

We have always been dedicated to lighting the way into compliance for health tech developers and innovators around the world. An easier regulatory journey for innovator means an increased chance to evolve their ideas into viable medical device manufacturers. As a result, we will see a growing number of life-altering medical innovations breakthrough to the…

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Medical Device Regulatory Journey: Interview with CEO Heikki Pitkänen

17th July 2020

Innovation in the healthcare industry is skyrocketing. There is a massive ongoing effort of adoption of healthcare technology globally. However, entering the healthcare market is still very complicated. One of the biggest challenges burdening the health tech industry is regulatory compliance. Medical device startups around the world fall into a trap, where they take substantial…

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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…

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Health tech Innovations in between legislations

27th April 2018

This blog article was originally published as an expert article by MedTech Finland. The European legislation on health tech is changing strongly. New regulations for medical devices enforce and unify the practices that have been proven most efficient throughout the decades. The regulations also contain responsibilities for importers and distributors to ensure patient safety and…

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The challenges of a health tech startup in the land of scattered Regulatory Information

6th September 2017

This blog article was originally published as an expert article in MedTech Views. MedTech Views is a platform for dialogue about medical technologies by MedTech Europe. According to the preliminary results of a study* aimed at the Finnish medical device industry, regulatory compliance pops up as the second biggest challenge burdening the industry. This, according to the study,…

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THE CALL FOR COOPERATION: How to Resolve Global Regulatory Challenges

27th June 2017

Dear Reader, The new European medical device regulations bring with them many awaited improvements. However, the amount of information and the number of cross-references they contain are not easily unlocked. The previous MEDDEVs and other Commission guidelines are now partly integrated with the regulations, but a great deal of updating is still required in order to…

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Requirement UX: Tables of Contents for the new Medical Device Regulations in EU

15th May 2017

Dear Reader, If you need Tables of Contents for the new European Medical Device Regulations, like we do, please download them from here:  Table of Contents - Medical Device Regulation (MDR) 2017/745 Table of Contents - In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 The Tables include links to the regulations, as published in their…

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Why we are Dedicated to Making Life Easier for Medical Device Startups

5th April 2017

Dear Reader, Years ago I worked for a medical device startup whose ambitions were bold and respectable. Their aim was to bring back at least some muscle movement for those who have been paralyzed. But it was a tough nut to crack. Even if we could've developed the technology, the regulations and standards didn't bend…

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