In addition to our ISO/IEC 17025 accreditation, our laboratories are also certified in accordance with the requirements of “Good Laboratory Practice” (GLP).
On request, we can test your medical devices as part of our biological assessment on the basis of this internationally recognised quality assurance system. This enables you to easily comply with the GLP requirements demanded by the authorities in many countries when authorising your products.
What is GLP?
Good Laboratory Practice (GLP) is a quality assurance system that defines the performance of non-clinical health and environmental safety tests as part of the (official) authorisation of legally regulated substances, preparations, materials and products, including medical devices.
The principles laid down by the OECD describe the organisational process and responsibilities as well as the conditions under which we plan, perform, monitor, record, report and archive the necessary laboratory tests for you.
With our GLP certification, we guarantee that the results of chemical, physical and biological tests on the biocompatibility of your medical devices are reproducible, fully documented and completely traceable. The data we provide is highly reliable and, thanks to its international comparability and recognition, makes it easier for you to take the next steps towards a rapid market launch of your products.
To the point – your benefits
- Comprehensive documentation, traceability and archiving of product tests
- Global comparability and acceptance of the determined test results
- Worldwide recognition of laboratory data by regulatory authorities
- Fulfilment of legal requirements when entering the market in countries with GLP requirements
