Lean Entries Articles

Public and private parties in Finland and Denmark have come together in a joint action to produce a catalogue of e-tools to explain and educate the industry on the Artificial Intelligence (AI) Act, Data Act and the European Health Data Space (EHDS) regulation. The target of these parties, by the lead and funding of The…

There can be a long way from a young company getting a good idea and it creating value in the healthcare sector. A new course in the Danish Life Science Cluster helps startups within life science and welfare technology to be ready for the market faster. Lotte Overbjerg,  (Translated by Google Translator. See the original text…

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…

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…

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…

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,…

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…

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…

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…