ISO News imageAugust 31, 2020

BRAUN Scandinavia A/S Achieves a Significant Milestone with ISO 13485:2016 Certification

We are very proud to announce that we have received the ISO 13485:2016 certificate!

In August 2020, BRAUN Scandinavia achieved the ISO 13485:2016 certification from Bureau Veritas – a global provider of certification services.

The ISO 13485:2016 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

We have developed and implemented our quality management system in order to make sure that we have indicated all possible risks towards patient safety and taken the necessary measurements to avoid risks. Our decision to work towards the ISO 13485:2016 accreditation demonstrates our commitment to provide consistent high-quality products and services to our clients, while taking this route we also prepare ourselves for the new Medical Device Regulation (MDR).

We are very proud of our ISO team and our whole organization for achieving this milestone. The ISO certification comes in the light of a strong team effort, and everyone in the team deserves great credit for their hard work and commitment to our quality management system.

The ISO 13485:2016 certification is the assurance that we need in order to work according to the latest standards and regulations, and to make sure that we can assure our partners that we have robust and clearly defined procedures in place.

Our Quality Department is happy to give you an answer to additional questions.
Contact them by sending a e-mail to quality@braun-scandinavia.dk