09 Okt. CeramOptec receives approval for medical technology
CeramOptec has successfully completed the Medical Device Single Audit Program (MDSAP), as the company has announced. The audit, conducted by DQS Medizinprodukte – an internationally accredited, independent certification institution in the field of medical technology – confirms the conformity of the quality management system with the ISO 13485:2016 standard and the country-specific quality requirements in the US, Canada, Japan, and Australia. As part of the audit, CeramOptec was certified for the development, manufacture, and servicing of sterile light guides, fiber optic transmission systems, and laser systems, including accessories. With the MDSAP seal of approval, the fiber optic specialist aims to strengthen its international orientation and regulatory expertise in the field of medical technology.
According to CeramOptec, the company is one of the few manufacturers worldwide that develops, produces, and distributes medical probes and laser beam sources entirely in-house. Roland Dreschau, Managing Director of CeramOptec, says: „MDSAP certification confirms our high-quality standards beyond European borders and facilitates access to international markets. This creates transparency and security for our partners and strengthens our position as a reliable supplier of fiber optic solutions in medical technology.“
Source and image: www.ceramoptec.com