Quality management (EN ISO 13485:2016)



Because of the international competition the synergetic deployment of a company is significant.

The efficient creation from a quality management system, which meets requirements of different target markets could be a huge barrier.

Our detailed advice as well as our industry-oriented experience in the interenational market is a great benefit.


We support you competently in establishing and maintaining your quality management system according e.g.: EN ISO 13485: 2016,

CRF Title 21 Part 820 ( Quality System Regulation- QSR )  and Part 11 for medicine products and also GMP and CFR Title 21 Part 210,211 (current Good Manufacturing Practice cGMP ) for combination products.


On request we also take on the following tasks: 

  • Implementation of your QM system
  • Auditing your QM system (1st party)
  • Supplier audits (2nd party)
  • Documentation

Please convince yourself of our expertise: medizintechnik@andreasstrauss.de.

We are looking forward to your inquiry.