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Regulatory Compliance and Quality
The Quality Management System is certified to the quality standards SS-EN ISO13485:2012 and for products delivered to the Canadian market ISO13485:2003 (CMDCAS).
The system is yearly audited by our notified body Intertek Certification AB. All medical devices delivered on the U.S. market have obtained market clearance from the Food and Drug Administration. All medical devices delivered on the European market conforms to the European Medical Device Directive 93/42/EEC and are handled under Hermes Medical Solutions EC-certificate. All medical devices delivered in Canada conforms to the Canadian medical device regulations (SOR98-282) and are handled under Hermes Medical Device License.