NEWS RELEASE: Hohenstein Medical Earns GLP Certification for Medical Device Testing
Good Laboratory Practice certification expands company’s ability to support medical device manufacturers in meeting the complex demands of international regulatory frameworks
BOENNIGHEIM, Germany & LIGONIER, Indiana — Hohenstein Medical, a division of Hohenstein Laboratories, announced it is now certified to conduct medical device testing in accordance with the internationally recognized Good Laboratory Practice (GLP) standard. The accreditation covers chemical, physical and biological safety testing—reflecting an extensive scope not commonly achieved by others in the industry.
“Our customers are producing life-saving devices that require accurate results, timely delivery and expert guidance,” said Dr. Timo Hammer, CEO of Hohenstein. “Our approach to GLP is a steadfast commitment to delivering those results for customers, by building trust and giving them the peace of mind knowing that we meet regulatory requirements in the areas that matter most to them.”
A division of Hohenstein, a leading provider of independent testing, research and certification services with more than 75 years of scientific experience and involvement in international standard development, Hohenstein Medical conducts biocompatibility testing for medical devices, including chemical screenings, biological in-vitro tests and microbiological evaluations such as bioburden and barrier effectiveness. GLP-compliant studies are recognized by regulatory authorities worldwide, including the U.S. Food and Drug Administration (FDA), and are often required for product approvals in major markets. With GLP certification, Hohenstein expands its ability to support medical device manufacturers in meeting the complex demands of international regulatory frameworks. GLP-relevant data at Hohenstein is primarily stored digitally. A climate-controlled paper archive has also been built at the company’s headquarters in Boennigheim, Germany.
“We are pleased that in addition to our existing ISO 17025 accreditation we now meet all criteria for GLP certification,” said Hammer. “This international standard enables global comparability and acceptance of our test results.”
GLP was developed to ensure the integrity and traceability of non-clinical laboratory data submitted to regulatory agencies. The standard outlines strict requirements for how health and environmental safety studies are organized, conducted and documented. It ensures quality assurance, traceability and regulatory compliance across personnel, facilities, materials, reporting and data archiving.
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About Hohenstein
Hohenstein is a leading provider of independent testing, research and certification services with expertise in medical devices, textiles and consumer goods. With more than 75 years of scientific experience and involvement in international standard development, Hohenstein supports manufacturers, suppliers and regulators with data-driven insights for product safety, quality and performance. The company is GLP certified for non-clinical safety testing of medical devices and conducts biocompatibility evaluations including chemical, biological and microbiological analysis. Hohenstein is also a CPSC-accepted third-party laboratory for CPSIA compliance and a founding member and leading provider of OEKO-TEX® services.
The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.
