Regulatory Compliance and Quality
The Quality Management System is certified to the quality standards ISO13485:2016 and Medical Device Single Audit Program MDSAP for Canada.
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.
All information on this website regarding products and services provided by Hermes Medical Solutions (HMS) is subject to change without notice. Reasonable efforts are taken to ensure the accuracy and integrity of all information provided here, but Hermes is not responsible for misprints, out-of-date information, or errors. Hermes makes no warranty, express or implied, or assumes any legal liability or responsibility for the accuracy or completeness of any information contained on this website. Contact your local Hermes Medical Solutions representative to find out more about our offerings in your region.