In order to have a safe, traceable and manageable Quality Management System in Confluence we need to first take care of our user management. Controlled actions performed by the right people is the cornerstone of developing a safe product. Let’s first review a few definitions, we will then describe the goal of Quality Management System […]
What is a Technical File?
The Technical File is a dossier required for marketing a medical device in Europe (a.k.a. receiving the CE mark). For Class III devices, this is called Design Dossier and has a few additional requirements. The Technical File is intended to show compliance with the applicable MDDs ( Medical Device Directives, the EU regulatory framework for […]