Logo Medical XPRT
Companies
Products
Services
Software
Training
Applications
Sign in
List your business
Hofer GmbH & Co KG
About
  2. Companies
  3. Hofer GmbH & Co KG
  4. Services
  5. Quality Management Services

Quality Management Services

SHARE

Our products and services meet the highest standards in terms of quality and safety. All company processes - from development to production to sales - take place in Austria, at our company headquarters in Fürstenfeld. The continuous improvement of our processes, the partnership with our customers and the manufacture of innovative products that meet the highest quality standards are always in the foreground for us.

Most popular related searches
ISO 13485 standard
ISO 13485
health surveillance
medical device
implant
osteosynthesis

Quality standards

Hofer has a certified quality management system that meets the requirements of the EN ISO 13485:2016 standard. In addition, a quality assurance system for the design, manufacture and final inspection of implants and instruments for osteosynthesis was introduced and applied, which meets the requirements of Annex II - excluding Section 4 of the EC Directive 93/42 EEC. Compliance with these requirements is regularly monitored by our Notified Body. In addition, other national guidelines and legal requirements are applied, such as the Austrian Medical Devices Act or the GMP requirements of the Brazilian authority for health surveillance ANVISA.