Achieving MDR compliance is a significant milestone in Sanatmetal’s life!

The European Union and the European Commission are committed to enhancing patient safety, which is why the EU is setting significantly higher requirements for medical device manufacturers under the MDR Regulation. May 26, 2024, marks a crucial milestone for this regulation. From this date onward, manufacturers must fully align their quality management systems with MDR requirements to maintain CE marked products on the market.

From May 13 to 23, 2024, the MDR-designated CE Certiso certifier, along with 5 auditors, thoroughly examined Sanatmetal’s entire quality management system, its MDR compliance, product development, manufacturing processes, and thousands of documents.

This audit, which we have honorably passed the longest and most comprehensive since the company’s first ISO certification 30 years ago, concluded with commendations and congratulations.