Knowledge Base
on quality and regulations

What is a QMS and why does quality management matter so much in medtech companies?

For medical device manufacturers, a quality management system (QMS) is an obligation under the MDR and, since February 2026, under the US QMSR too. We explain what a QMS is, what the MDR and ISO 13485 require and what separates a working system from one that exists only on paper.

Zespół NexiMed

9 min read