CeramOptec receives international seal of approval for medical technology

MDSAP certification confirms global regulatory expertise and strengthens presence at COMPAMED 2025

CeramOptec strengthens its international position in the medical technology industry with certification under the Medical Device Single Audit Program (MDSAP). The award confirms the conformity of the quality management system with the ISO 13485:2016 standard and the regulatory requirements in Australia, Canada, Japan, and the USA.

Bonn/Livani, September 9, 2025 – CeramOptec has successfully completed the Medical Device Single Audit Program (MDSAP). The audit, conducted by DQS Medizinprodukte GmbH, an internationally accredited, independent certification body 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 USA, 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 underscores its international orientation and regulatory expertise in the field of medical technology. In addition, CeramOptec is one of the few manufacturers worldwide that develops, produces, and markets medical probes and laser beam sources entirely in-house.

Roland Dreschau, Managing Director of CeramOptec, emphasizes: “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.”

Experience it live at COMPAMED 2025

Interested parties will have the opportunity to find out more about the company’s medical technology portfolio at COMPAMED (November 17 to 20, 2025, in Düsseldorf, Hall 8a, Booth F29-1). Innovative solutions for medical laser applications and fiber optic systems will be presented at the booth, including biocompatible fibers with customer-specific core diameters and non-circular geometries that are particularly suitable for use in laser surgery, optical imaging, endoscopy, and spectroscopic diagnostics.

CeramOptec will also be showcasing customized probe assemblies that can be manufactured precisely to specification – ideal for OEM applications in a wide range of medical disciplines. In addition, the company will be presenting in-house sterilization processes and options for large-scale production that guarantee maximum process reliability and reproducibility.

Another highlight: All fibers can be provided with individual, abrasion-resistant markings on request to facilitate traceability and handling in clinical environments. This underscores CeramOptec’s position as a reliable partner for customized fiber optic components in modern medical technology.

Further information about CeramOptec and the solution portfolio presented at the trade fair is also available online at www.ceramoptec.com.