Quality Management
Seamless quality is not an option – it is the foundation of every product that leaves our facility.
In medical technology, quality is not a marketing statement, but an ethical obligation. Our quality management system is certified in accordance with ISO 13485:2021 and EU Medical Device Regulation 2017/745 and covers the entire product lifecycle – from development and manufacturing through to post-market surveillance.
All processes and products are reviewed annually by our notified body, DNV MedCert, and through customer audits – for our own products as well as for the services we provide for third-party products.
To deliver consistently high quality, a quality management system also requires comprehensive quality assurance. This begins with incoming inspection of materials and goods, continues throughout production and concludes with the final release inspection.
In addition to an extensive selection of various measuring instruments and component-specific test equipment, we have measuring machines for tactile, optical and roughness inspections – all of course in an air-conditioned environment.