Hohenstein achieves GLP Certification for Medical Device Testing

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.”