NeuroLogica receives CE mark for all Elite mobile CT systems
October 14, 2022 — NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., announced today that its state-of-the-art Elite mobile computed tomography (CT) systems have received the European Union (EU) CE Mark through compliance with the new EU Medical Device Regulation (MDR 2017/745). Assessment and certification by an EU Notified Body includes the approval of the mobile CT systems OmniTom Elite, BodyTom Elite and CereTom Elite.
“Receiving this certification shines a light on our continued commitment to bringing innovative solutions to hospitals and clinics around the world,” said Jason Koshnitsky, Senior Director of Global Sales and Marketing, NeuroLogica. “It will enable more healthcare professionals to have access to cutting-edge diagnostic imaging to provide superior patient care.”
The EU MDR (EU Medical Device Regulation 2017/745) replaced the previous EU MDD (Medical Device Directive 93/42/EEC). The updated regulations place a strong emphasis on technical documentation, clinical data and post-market surveillance. “NeuroLogica already complies with the US Food and Drug Administration’s quality system regulations and is certified to ISO 13485. Our products and processes comply with global regulatory requirements enabling the design, manufacture, installation, service and engineering of imaging systems for medical applications,” said dr. Ninad Gujar, Vice President of Regulatory Affairs, Quality Assurance and Corporate Compliance. “Compliance with the EU MDR is an important regulatory milestone that demonstrates NeuroLogica’s efforts to demonstrate compliance with EU regulatory requirements, making mobile CT systems available in the European Economic Area and remaining committed to product quality and safety.”
Currently providing advanced technology in more than 50 countries worldwide, NeuroLogica has existing partners in Europe who work as economic operators and an established network of distributors who continue to support customers. The company’s line of mobile CT products will continue to be manufactured in Danvers, Massachusetts in the United States, and will be exported to customers in the EU.
For more information: www.neurologica.com
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