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HOFER MEDICAL SOLUTIONS

Qualiy Management
Standards for Quality

 

Our Products and Services meet highest Safety and Qualtity standards. All internal processes from Product Development over Manufacturing to Sales and Distribution are taking place at our Austrian Headquarter in Fuerstenfeld. Our main focus reflects on continious improvement of our processes, cooperation in close partnership with our customers, and the production of innovative products according to highest quality standards.

Quality Standards


Hofer Medical Solutions follows a certified Quality Management System meeting EN ISO 13485:2016 standards. An additional Quality Managment System, following requirements according to Appendix II without Paragraph 4 of EG-Guideline 93/42 EWG, for the development, manufacturing and final quality check of Osteosynthesis-Implants, has also been implemented. Compliance with these regulations is subject to periodical audits by the responsible Notified Body. Additional Guidelines such as the Austrian MDD or GMP requirements of the Brazilian ANVISA Authority are applied according to local national regulations.


Notified Body:


mdc medical device certification GmbH
Kriegerstraße 6
D-70191 Stuttgart

Phone: +49-(0)711 253597-0 

Fax: +49-(0)711 253597-10
E-Mail: mdc@mdc-ce.de

Notified Body Homepage: MDC