We are testing medical devices for medical device manufacturers according to European (EN) and international (ISO) standards.
The test laboratory HygCen Germany GmbH is accredited and recognized by an independent body by DAkkS / ZLG according to EN ISO / IEC 17025 for testing of medical devices and ensures the quality assurance of medical devices worldwide by performing testings.
As a result of this competence and structure, HygCen is in a position to respond systematically and quickly to problems and offer solutions promptly.
The accredited quality assurance tests include:
• All current European efficacy tests of disinfectants including complete virucidal and sporicidal tests
• Biocompatibility tests of medical devices
• Testing the reprocessability medical devices
• Testing reprocessing processes
• Check of manual reprocessing steps
• Check of the cleaning efficacy, disinfection efficacy and the overall process
• Type testing of WD / WD-E and sterilizers
• Process validation of WD / WD-E and sterilizers
We would be pleased to discuss with you how we can support you in the quality assurance of your medical devices!
Please write to us at info@ or call us at +49 (0) 385 5682 65 hygcen.de