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Tecomet’s location in Kenosha, Wisconsin achieved certification to the European Union Medical Device Regulation (EU MDR
2017/745) for all Tecomet-designed products. Tecomet’s successful transition from the previous Medical Device Directive (MDD) to EU
MDR compliance underscores its robust quality management systems, continuous process improvement, and alignment with evolving regulatory expectations.
“This recognition is a great achievement by our Kenosha team and represents a significant amount of preparation and execution,” said Andreas Weller, President and Chief Executive Officer at Tecomet. “This regulatory achievement not only reflects our commitment to patient safety and product excellence but also ensures our readiness to support our European customers in navigating complex compliance landscapes.”
Tecomet successfully upgraded its already MDD-compliant Technical Files to meet the EU’s rigorous Medical Device Regulation (MDR). This intensive effort established new compliance benchmarks, reinforcing the Company’s dedication to regulatory and product excellence.
“With this certification, Tecomet remains well-positioned to support OEM partners in accelerating innovation while ensuring product integrity and regulatory adherence across the product lifecycle,” added Weller. “We look forward to further building partnerships rooted in trust, innovation and continuous improvement, while cementing our long-term commitment to premier quality and regulatory excellence.”
Source: Tecomet
