Our products conform to safety standards for our worldwide customers, including CE conformance according to EU low voltage and EMC directives, and equivalent UL/CSA in North America.
We maintain a FDA 21 CFR 820 oriented quality system to support our US customers.
We are regularly audited and inspected by
- DQS Medizinprodukte GmbH (ISO-9001, ISO-13485, annually)
- Intertek & CSA (UL/CSA conformance, quarterly), and
- Internal quality management