ISO/IEC 17025
Medical Device Testing Accreditation
Hohenstein is accredited by the German Accreditation Body (DAkkS) in accordance with ISO/IEC 17025 to perform biological, chemical and physical testing of medical devices.
ISO/IEC 17025:
- Demonstrates that testing is performed with validated methods, calibrated equipment and trained personnel
- Ensures accuracy, repeatability and international acceptance of results
- Important for proving technical competence of our laboratory
Good Laboratory Practice (GLP)
Medical Device Testing Certification
Hohenstein is among the few medical device testing labs accredited in chemical, physical and biological testing.
GLP (Good Laboratory Practice):
- Demonstrates compliance with internationally recognized quality principles for study planning, conduct, reporting and archiving
- Required by many regulatory authorities (FDA, EU MDR, etc.) for biological safety assessments
- Important for ensuring data integrity, transparency and traceability in regulatory submissions