Brasseler implements a certified quality management system in accordance with the EN ISO 9001 and EN ISO 13485 standards for the development, manufacturing and sale of medical and industrial products. This ensures that our company processes are aligned specifically to the needs and requirements of our customers.

In order to fulfil the highest customer demands, clear specifications and processes are essential. Ongoing traceability ensures reproducible quality. Specialised expertise and modern machine and system technology ensure we can implement our commitment to quality reliably and consistently.

The Certificates:

• No. HD 60135991 0001
  Approval based on Directive 93/42/EWG Annex II
• No. SX 1470094-1
  Certificate – EN ISO 13485:2016
• No. DE AEOC 108049
  AEO Certificate
• No. 01 100 1810031
  Certificate – ISO 9001:2015
• No. HZ 1470094-1
  MDR-Certificate
  REGULATION (EU) 2017/745 on Medical Devices
• No. MD 1090723-40
  Certificate ISO 13485:2016 MDSAP