Hermes Medical Solutions receives EU MDR certificate and CE marking for its medical software applications
Hermes Medical Solutions (HMS), a global market leader in molecular imaging and dosimetry software, has received its EU Medical Device Regulation (MDR) certificate. All upcoming releases of our software applications for Nuclear Medicine, Molecular Imaging and dosimetry are compliant with the new European legislation for medical devices software.
Delivering high-quality medical software applications in Europe and worldwide
The Medical Device Regulation (MDR) is the law to follow to make medical devices available on the European market. The regulation is extensive and has brought stricter requirements for a manufacturer of medical devices like us. It should increase the safety and performance of the products placed on the European market and consequently benefit the patients. We, at HMS, have updated our Quality Management System (QMS) to comply with these requirements and the QMS serves as a framework for all the products we release worldwide.
HMS has received certification under the MDR and is entitled to use the CE marking on the software applications within Hermia, the umbrella name given to the whole software, and this for two different risk classes. Our software applications for viewing, analysis and processing of nuclear medicine and molecular imaging have been certified as class IIa. Our dosimetry applications like Olinda and Voxel Dosimetry are certified as class IIb.
“Receiving the MDR certificate shows our renewed commitment to providing the highest level of quality and safety to our customers and their patients. Our updated QMS gives us a strong advantage and base to continue developing great software products while ensuring the safety of patients.” says Tom Francke, CEO at HMS.
About Hermes Medical Solutions
Hermes Medical Solutions continuously innovates to enable faster and more personalized diagnosis and therapies in molecular imaging. With Hermia, we empower healthcare professionals with state-of-the-art software for all clinical scenarios into ONE vendor-neutral platform. Powerful tools enable clinicians to simplify their workflow and keep pace with the fast development of scanners, tracers and procedures in nuclear medicine. The result is improved quality in patient management and decision support for thousands of healthcare providers and their patients worldwide.
www.hermesmedical.com
Contact
Tom Francke
CEO, Assoc. Prof.
Hermes Medical Solutions AB (HQ)
Strandbergsgatan 16
112 51 Stockholm, Sweden
Tel: +46 70 166 1234
tom.francke@hermesmedical.com