CIRCA Scientific's Quality Management System Awarded EU-MDR Certification

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Sep 07, 2022, 15:17 ET

CIRCA Scientific's products meet new, strengthened requirements for safety and performance in Europe.

ENGLEWOOD, Colo., Sept. 7, 2022 /PRNewswire/ -- CIRCA Scientific announced that the company has successfully met the requirements for certification of its Quality Management System (QMS) under the new European Union Medical Device Regulation (MDR) as of August 24^th, 2022. To earn this certificate, BSI Group, CIRCA Scientific's notified body, completed a comprehensive conformity assessment and confirmed compliance of its QMS with the new, strengthened safety and performance requirements of the MDR. MDR certification allows CIRCA Scientific not only to continue to distribute its existing products in European markets but opens the door to proceed with its plans for new product developments and launches in the EU.

The new Medical Device Regulation went into effect in May of 2021 and replaces the EU's Medical Device Directive. Compared to previous directives, the MDR has more stringent requirements concerning documentation, clinical evidence, and post-market surveillance, as well as more comprehensive QMS requirements for medical device manufacturers. As a result, more than 85% of the products previously certified under the old MDD have yet to receive this certification, and notified bodies are currently taking 13-18 months to issue MDR certification.¹

Lee Geist, President and CEO of CIRCA Scientific, said, "This regulatory certification is an important milestone for CIRCA Scientific, and we are proud to count our CIRCA Temperature Monitoring System among the first products to be certified under the new MDR. I'd like to acknowledge the tireless work of our Quality Assurance team who managed all the activities required to establish compliance with the new regulation. This a huge company-wide achievement that will ensure that we are able to continue to supply our valued customers around the globe with our best-in-class esophageal temperature monitoring solutions and to launch our latest developments in this region without delay."

About CIRCA Scientific
For the last 10 years, CIRCA Scientific has been the global leader in Advanced Esophageal Temperature Monitoring Solutions. CIRCA's Esophageal Temperature Monitoring Systems provide physicians with rapid, reliable data to help them avoid excessive heating/cooling of the esophagus during therapeutic procedures performed in the OR or EP Lab. For more information, visit www.circascientific.com and connect with us on Twitter and LinkedIn.

References: ¹ https://www.medtechdive.com/news/legacy-devices-lack-mdr-certificates-medtech-europe/627439/

SOURCE CIRCA Scientific, Inc.