Successful initial certification according to MDSAP

Following a recent audit by a notified body, DeltaMed GmbH was certified for the first time in accordance with MDSAP.

The Medical Device Single Audit Program (MDSAP) was developed as a common standard for regulatory quality management audits and serves as a prerequisite for marketing medical devices in the participating countries Australia, Japan, Brazil, the USA and Canada.

“For us as a manufacturer, it is essential to satisfy the legal and formal requirements to sell our products in the target countries. This is particularly beneficial for our partners and customers. Our expertise contributes significantly to bringing our products to market quickly and in a legally compliant and sustainable way,” emphasized Rüdiger Lange, Quality Management Representative at DeltaMed GmbH.

DeltaMed medical devices are available on six continents and are produced exclusively at the Friedberg (Hesse) site in Germany.

 

About DeltaMed

DeltaMed GmbH develops and produces materials for various dental, medical, and technical applications. Core competences include material and process development for additive manufacturing approaches. Other focus areas include the development and production of light-curing materials for restorative dentistry and dental technology.

DeltaMed is part of the Prodways Group, a corporation headquartered in Paris, which offers integrated solutions for the entire 3D printing supply chain, including equipment, materials, processes, and software.

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