Lean Entries Blog

Medtech Innovations in between Legislations

This blog article was originally published as an expert article by MedTech Finland. The European legislation on medtech 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 the…

Read More

The challenges of a MedTech startup in the land of scattered Regulatory Information

We are discussing the challenges of a medtech startup in the MedTech Views blog article published on 6 Sep 2017. MedTech Views is a platform for dialogue about medical technologies by MedTech Europe.

Read More

THE CALL FOR COOPERATION: How to Resolve Global Regulatory Challenges

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…

Read More

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

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…

Read More
Compliance Meet Platform: Why are we dedicated to making life easier for medical device startups

Compliance Meet Platform: Why are we dedicated to making life easier for medical device startups

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…

Read More