QM & Certificationsadmin
Only through security, quality and sustainability we create values and new perspectives in the production of medical OEM products, custom-made products and innovative new developments.
With the careful adherence to all legal requirements, quality management according to the highest requirements and a complete documentation of all production steps and all raw materials used, we create a stable and solid basis for a trusting and long-term cooperation with you.
Certification according to DIN EN ISO 13485 (ISO 9001)
We attach great importance to careful quality management for the production of our products, which is certified according to DIN EN ISO 13485. In essence, this standard corresponds to the earlier DIN ISO 9001, but relates to specific requirements for medical products, e.g. With regard to product safety, documentation and the establishment of risk management for the products.
As a manufacturer certified according to DIN EN ISO 13485, we create a device master file for each of our products, carry out a risk management report and report our product range to the German Institute for Medical Documentation and Information. Any medical OEM or specialty product manufactured by us complies with the requirements laid down in the European Union harmonization legislation and may bear the CE marking.
As a manufacturer of medical devices, we carefully take care that our production facilities comply with the regulations of the US Food and Drug Administration (FDA). Our plants have been audited by the FDA and approved for the manufacture of medical devices for marketing on the US market.
A complete documentation of all production steps and the origin of all raw material batches used in production is self-evident in the production of OEM medical products and Customized / Bespoke products.
Any product range for classical or one-way instruments manufactured for you will always be accompanied by all certificates and certificates up to the origin of the steel grades used.
Your trust is our capital, so we always offer you the highest transparency and open, binding communication. Whatever information you need from us – Contact us!