Sam Brusco, Associate Editor10.14.22
Samsung subsidiary NeuroLogica has earned a CE mark for its Elite mobile computed tomography (CT) systems under the new EU Medical Device Regulation (MDR).
The approval includes the OmniTom Elite, BodyTom Elite, and CereTom Elite mobile CT systems.
“The achievement of this certification sheds light on our continued dedication to bringing innovative solutions to hospitals and clinics globally,” Jason Koshnitsky, sr. director global sales and marketing, NeuroLogica told the press. “It will allow a greater number of healthcare providers to have access to cutting-edge diagnostic imaging to deliver high-end patient care.”
“NeuroLogica already complies with the United States Food and Drug Administration quality system regulations and is certified to ISO 13485 standard. Our products and processes comply with global regulatory requirements allowing design, manufacturing, installation, service and engineering of imaging systems for medical applications,” said Dr. Ninad Gujar, VP of regulatory affairs, quality assurance, and corporate compliance. “Compliance with EU MDR is an important regulatory milestone that exhibits NeuroLogica’s efforts towards demonstrating conformance to EU regulatory requirements, making mobile CT systems available in the European Economic Area and remaining committed to product quality and safety.”
The company’s mobile CT line will continue to be manufactured in Danvers, Mass. and will be exported to EU customers.
The approval includes the OmniTom Elite, BodyTom Elite, and CereTom Elite mobile CT systems.
“The achievement of this certification sheds light on our continued dedication to bringing innovative solutions to hospitals and clinics globally,” Jason Koshnitsky, sr. director global sales and marketing, NeuroLogica told the press. “It will allow a greater number of healthcare providers to have access to cutting-edge diagnostic imaging to deliver high-end patient care.”
“NeuroLogica already complies with the United States Food and Drug Administration quality system regulations and is certified to ISO 13485 standard. Our products and processes comply with global regulatory requirements allowing design, manufacturing, installation, service and engineering of imaging systems for medical applications,” said Dr. Ninad Gujar, VP of regulatory affairs, quality assurance, and corporate compliance. “Compliance with EU MDR is an important regulatory milestone that exhibits NeuroLogica’s efforts towards demonstrating conformance to EU regulatory requirements, making mobile CT systems available in the European Economic Area and remaining committed to product quality and safety.”
The company’s mobile CT line will continue to be manufactured in Danvers, Mass. and will be exported to EU customers.