Accreditations and certifications
DAkkS accreditation for the biology laboratory in Liptingen
Our laboratory is accredited by the German Accreditation Body in accordance with DIN EN ISO 17025:2018 in the field of medical devices, and we have been granted recognition by ZLG in accordance with Regulation (EU) 2017/745 (MDR).
The biology laboratory in Liptingen is accredited according to DIN EN ISO/IEC 17025:2018 for biological, chemical, and microbiological-hygienic testing of medical devices, as well as microbiological-hygienic testing of raw materials (active ingredients and excipients) and intermediate products of medical devices in accordance with Section 3 (2) MPG (Medical Devices Act) and hygienic environmental monitoring.
The scope of accreditation also includes chemical tests to determine the TOC as part of chemical characterization in accordance with DIN EN ISO 10993-18 or as part of cleanliness testing in accordance with ISO 19227. Furthermore, the scope of accreditation includes microbiological and hygienic tests as part of routine monitoring of cleaning and disinfection devices with chemical or thermal disinfection, also for thermolabile endoscopes, extended by means of bioindicators.
In addition, the accreditation under registration number D-PL-19887-03-00 covers microbiological hygiene testing of surfaces and air in the healthcare sector (hygiene/hospital hygiene) using contact plates and sedimentation plates.
Accreditation of the Leipferdingen Chemistry Laboratory
Our chemical laboratory in Leipferdingen is accredited according to DIN EN ISO/IEC 17025:2018 for chemical testing within the scope of chemical characterization according to DIN EN ISO 10993-18.
GLP accreditation for biology laboratory in Liptingen
Our testing facility is subject to national GLP monitoring procedures and is regularly monitored for compliance with GLP principles in accordance with the Chemicals Act and Directive 2004/9/EC.
Good Laboratory Practice (GLP) is a quality assurance system for laboratories that conduct non-clinical testing in the health and environmental sectors. GLP accreditation enables tests conducted in accordance with GLP principles to be mutually recognized by the regulatory authorities of OECD member countries*, meaning that test results are also accepted by the FDA.
* Europe, USA, Canada, Japan, Mexico, Australia, and others
- GLP certificate409 KB
ZLG accreditation for biology laboratory in Liptingen
The ZLG has recognized our laboratory's competence for biological and microbiological-hygienic testing of medical devices in accordance with the applicable regulation.
Recognition by the ZLG (Central Authority of the German Federal States for Health Protection in the Field of Medicinal Products and Medical Devices) in accordance with Section 18 of the Medical Devices Implementation Act (MPDG) confirms that the requirements for a testing laboratory in accordance with Regulation (EU) 2017/745 [MDR] and DIN EN ISO/IEC 17025:2018.
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