Hohenstein: 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. 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.
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.
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. In some countries – for example, the United States – GLP testing is even a regulatory requirement."
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.
Hohenstein
