Tecomet Inc.’s Kenosha, Wis., location earned EU Medical Device Regulation (EU MDR) certification for all products.

The MDR is considered one of the most rigorous regulatory frameworks (globally) that govern medical device production and distribution in Europe. Tecomet’s successful transition from the previous Medical Device Directive (MDD) to EU MDR compliance underscores its 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,” Tecomet President/CEO Andreas Weller said. “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 upgraded its MDD-compliant Technical Files to meet the MDR requirements. This 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,” Weller added. “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.”

Headquartered in Woburn, Mass., with more than 16 facilities worldwide across three continents and five countries, Tecomet designs, develops, and manufactures orthopedic, robotic assisted, and minimally invasive surgical products. Tecomet offers metal and material conversion technologies for long-term implants and instrument solutions, including forging, casting, precision-machining, and other value-add services. Tecomet also manufactures precision components for the aerospace and defense industry, producing items used in aircraft engines, missile and satellite propulsion systems, vision systems, and infrared applications. Tecomet meets ISO 9001, AS9100, ITAR, and ISO 13485 requirements.