Quality assurance

State of the art manufacturing processes ensure a high level of quality products in combination with cost efficiency. We are convinced only high quality implants and instruments will meet the latest requirements of the market for the patient safety. The obligation to ensure highest degree of reliability and quality of our implants is forcing us to an extremely close collaboration with selected partners.

We ensure at all times the processed materials of our implants to meet the strict requirements of biocompatibility as well as the mechanical properties. As a result, our customers get maximized safety without compromises.

Since 1997 AF MEDICAL is certified according to EN ISO 9001 and EN 46001 (CE / EN) and later according to the latest standards according DIN EN 13485. AF MEDICAL`s quality is market orientated, enabling us to fully satisfy the expectations of our customers. As a result, our production methods, product finishes and services are orientated towards customer requirements and indications.

Quality manufacturing leads to quality awareness, with well selected partners and well trained employees in combination of modern technologies quality is achieved and maintained at the highest possible level. As a matter of course, our productivity system is always compliant to the quality management system according to DIN EN 13485:2016.
This guarantees systematic significance to quality assurance from the beginning in the development until the ready product is being held in hands for full customer satisfaction.

Find our latest certificates in the download section.