#Research & Development

2025-07-24

Hohenstein achieves GLP Certification for Medical Device Testing

Since the middle of July, the testing service provider Hohenstein has been certified to conduct medical device testing in accordance with the internationally recognised Good Laboratory Practice (GLP) standard. This certification comprehensively covers chemical, physical and biological safety testing of medical devices.

Since the middle of July, the testing and research service provider Hohenstein has been able to guarantee the internationally recognized standard of “Good Laboratory Practice” (GLP) for the testing of medical devices since © 2025 Hohenstein

The standard focuses on the organisational procedures and documentation of non-clinical health and environmental safety studies and their framework conditions. GLP ensures that all necessary requirements regarding quality assurance, documentation and safety are met. This applies to the organisation and personnel as well as facilities, test and reference items, study reports and archiving.

A Key Milestone

"We are pleased that in addition to our existing ISO 17025 accreditation, we now meet all the criteria for GLP certification. This international standard is a key milestone for our medical device testing portfolio," says Dr Timo Hammer, CEO of Hohenstein. "It enables global comparability and acceptance of our test results for our customers."

Under GLP, Hohenstein Medical primarily conducts biocompatibility testing for medical devices. This includes chemical screenings and biological in-vitro tests, as well as microbiological tests such as bioburden and barrier effectiveness. Thanks to a high-quality and reliable quality assurance system, GLP-compliant laboratory tests are recognised by regulatory authorities worldwide. "This can accelerate product approvals and shorten time-to-market," Dr Hammer continues. “In some countries – for example, the United States – GLP testing is even a regulatory requirement.”

State-of-the-art Archive

At Hohenstein, GLP-relevant data is primarily stored digitally. In addition, a state-of-the-art, climate-controlled paper archive has been constructed at the company headquarters in Boennigheim. "Alongside regulatory requirements, our understanding of Good Laboratory Practice at Hohenstein includes one essential element," adds Dr Hammer. “It is important to us to provide personal support to our customers, process orders as quickly as possible and apply our full expertise.”

Under GLP, Hohenstein Medical primarily offers tests on the biocompatibility of medical devices, such as chemical screenings and biological in-vitro tests, as well as tests on microbial load and microbial barrier. © 2025 Hohenstein

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Testing and research laboratory ensures safe and more sustainable products worldwide

For 80 years, Hohenstein has stood for independent testing, scientific expertise and practical solutions. Today, the testing and research service provider supports manufacturers and brands worldwide in making textiles, hardlines and medical devices safe, more sustainable and market-ready – thereby building trust among consumers. With an international presence and interdisciplinary expertise, Hohenstein supports its customers from production through to market launch, helping them navigate an environment of growing regulatory and societal demands.

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