Stratus EEG™ is one of the first clinical EEG products to receive MDR approval and CE mark under new EU Regulation.
IRVING, TX. (August 21, 2023) – Kvikna Medical, the international electroencephalogram (EEG) software and hardware division of Stratus, today announced it has received European Medical Device Regulation certification from its certified body the British Standards Institution (BSI). This certification ensures that Kvikna Medical can continue to deliver innovative solutions to hospitals and physicians in the European Union and beyond.
The certification specifically applies to Stratus EEG™, Kvikna’s EEG software system that allows for acquisition, display, analysis, and storage of physiological signals. The software is designed to accommodate the data, monitoring, and reporting needs of individual physicians, hospitals, and healthcare systems. The Stratus EEG software is classified as a Class IIa device in accordance with rule 11 of Annex VIII of the MDR 2017/745.
Regulation MDR (EU) 2017/745 replaces the former European Medical Device Directive (93/42/EEC). The new Regulation describes the requirements and conformity assessment procedures that must be met before medical devices are introduced into the European Economic Area. It was established to set EU-wide rules to improve the safety and quality of medical devices, as well as transparency for patients to protect public health and patient safety. Kvikna Medical’s completion of the new process prior to the extended 2028 deadline helps to ensure the EU market has timely access to new products from the company.
“Stratus EEG is one of the first clinical EEG products to receive MDR certification and we are very proud of this accomplishment”, said Gardar Thorvardson, CEO of Kvikna Medical. “Gaining MDR approval now is a testament to the strength of the company’s quality and risk management systems and the overall caliber of our products. Kvikna Medical is highly committed to excellence in its products and internal processes and always strives to achieve the highest standards. In addition to MDR, the company also has ISO13485 and 14971 certifications.”
To learn more about Stratus EEG software and Kvikna Medical, visit www.stratusEEG.com.
About Kvikna Medical
Kvikna Medical was founded in 2008 to develop and market new and innovative EEG solutions and to make EEG monitoring more accessible to both clinicians and patients. The Stratus EEG™ software is used by thousands of neurologists across the globe to help diagnose and treat people with neurological disorders. Kvikna Medical is a division of Stratus, a privately held company and the largest provider of EEG solutions in the United States.
Originally posted on PRweb.com.