Smithers Germany medical device testing lab achieves ISO/IEC 17025

Akron, OH – Smithers announces that its Germany Medical Device Testing laboratory is formally accredited to the internationally recognized ISO/IEC 17025 standard for testing and calibration laboratories. This accreditation reaffirms the lab’s technical competence and commitment to delivering accurate, reliable data that supports product development and regulatory submissions for pharmaceutical and medical device manufacturers across Europe and globally.

The ISO/IEC 17025 accreditation is the definitive benchmark for laboratory quality and operational excellence, underscoring the facility’s robust quality management systems, validated testing methods, and calibrated equipment operated by highly trained scientists and engineers. Achieving this accreditation enhances the lab’s ability to provide globally accepted test results, enabling clients to demonstrate regulatory compliance more efficiently and bring products to market faster.

“Earning ISO/IEC 17025 accreditation is a milestone that reflects our unwavering dedication to quality, scientific rigor, and regulatory integrity,” said Michael Zier, Laboratory Operations Manager, Smithers Medical Device Testing Division. “Our clients depend on trusted data to make critical product decisions — this certification further strengthens their confidence in our analytical, physical, and functional testing services.”

Located in Neu-Isenburg near Frankfurt, the Smithers Germany Medical Device Testing laboratory provides a broad range of services that support the entire medical device lifecycle, including materials analysis, design verification, functional performance testing, and packaging evaluation. The facility’s accreditation ensures that all test results are traceable, reproducible, and consistent with global regulatory expectations. The Germany laboratory complements Smithers established Medical Device Testing laboratories in the United Kingdom and the USA, providing clients with access to consistent testing capabilities across key global markets.

“As regulatory requirements continue to evolve, particularly under MDR in the EU and other global frameworks, our clients benefit from having an accredited test partner here in mainland Europe,” added Gael Peron, President, Smithers Medical Device Testing Division. “This accreditation enables faster regulatory engagement, more efficient design cycles, and better alignment with international quality expectations.”