BOENNIGHEIM (msc) 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. 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.”
More details: www.hohenstein-medical.com
About Hohenstein
Hohenstein is a family-owned company with more than 75 years of experience in testing, certification and research. Customers around the world benefit from a one-stop service: around 1,500 employees support businesses along the entire value chain, from testing and certification to marketing their products. Hohenstein’s testing portfolio includes softlines – textile materials –, hardlines – consumer goods made from rigid materials –, as well as medical devices. As an accredited testing laboratory, Hohenstein Medical provides independent evidence of the effectiveness and safety of medical devices through biological, chemical and physical laboratory tests. The Hohenstein experts also support their customers with interdisciplinary knowledge for customised testing solutions beyond standard methods.
www.hohenstein.com
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