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.
Media Contact
Jennifer Armstrong, Stratus, 1 9727438992, [email protected], www.stratuseeg.com
SOURCE Stratus
