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Hohenstein has been officially certified to conduct medical device testing under the internationally recognized Good Laboratory Practice (GLP) standard. GLP certification expands a company’s ability to support medical device manufacturers in meeting the complex demands of international regulatory frameworks.
The company says that GLP certification ensures rigorous standards for quality assurance, documentation, and safety in non-clinical health and environmental studies. It applies to all aspects of the testing process, including personnel qualifications, facilities, procedures, reporting and archiving.
“We are pleased to now meet all GLP requirements,” said Dr Timo Hammer, CEO of Hohenstein. “This boosts global acceptance of our test results, accelerates product approvals and shortens time-to-market for our clients.”
A division of Hohenstein, a 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.
Hohenstein, based in Boennigheim, Germany, is also a U.S. Consumer Product Safety Commission (CPSC)-accepted third-party laboratory for CPSIA [Consumer Product Safety Improvement Act] compliance and a founding member and provider of OEKO-TEX® services.