Lumis Life Science Consulting

Regulatory pathways for medical device clinical trials

This article summarises the procedures to get study approval for medical device clinical trials. Along with the intricacies of the Medical Device Regulation (EU) 2017/745, Lumis Life Science Consulting provides an important summary of medical device study classifications and the corresponding submission pathways.

How to transition your study to CTR 536/2014

The challenges in effective vendor management

Vendor management – more than relationship management?

Rescue clinical trials

Decentralised clinical trials oversight management

Managing vendors means managing relationships