Het portfolio van mobiele CT-scanners van het bedrijf om hoogwaardige CT-beeldvorming te blijven leveren op de point-of-care binnen de Europese Unie.
DANVERS, Massachusetts–(BUSINESS WIRE)– NeuroLogica Corp., een dochteronderneming van Samsung Electronics Co. Ltd., heeft vandaag aangekondigd dat haar ultramoderne Elite Mobile Computed Tomography (CT)-systemen de Europese Unie (EU) hebben ontvangen ) CE-markering via naleving van de nieuwe EU-verordening voor medische hulpmiddelen (MDR 2017/745). De beoordeling en certificering die is uitgevoerd door de aangemelde instantie van de EU omvat de goedkeuring van de OmniTom Elite, BodyTom Elite en CereTom Elite mobiele CT-systemen.
“Het behalen van deze certificering werpt licht op onze voortdurende toewijding om innovatieve oplossingen te bieden aan ziekenhuizen en klinieken over de hele wereld”, zegt Jason Koshnitsky, Sr. Director Global Sales and Marketing, NeuroLogica. “Het zal een groter aantal zorgverleners toegang geven tot geavanceerde diagnostische beeldvorming om hoogwaardige patiëntenzorg te leveren.”
NeuroLogica Receives CE Marking for all Elite Mobile Computed Tomography Systems
The company’s portfolio of mobile CT scanners to continue delivering high-quality CT imaging at the point-of-care within the European Union.
DANVERS, Mass.–(BUSINESS WIRE)– 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 marking via compliance with the new EU Medical Device Regulation (MDR 2017/745). The assessment and certification completed by the EU’s Notified Body includes the approval of the OmniTom Elite, BodyTom Elite and CereTom Elite mobile CT systems.
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NeuroLogica has received the European Union CE marking via compliance with the new EU Medical Device Regulation for its Elite Mobile Computed Tomography systems. (Photo: Business Wire)
“The achievement of this certification sheds light on our continued dedication to bringing innovative solutions to hospitals and clinics globally,” said Jason Koshnitsky, Sr. Director Global Sales and Marketing, NeuroLogica. “It will allow a greater number of healthcare providers to have access to cutting-edge diagnostic imaging to deliver high-end 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 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, Vice President 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.”
Currently providing advanced technology to more than 50 countries globally, NeuroLogica has existing partners in Europe working as Economic Operators and an established network of distributors to continue to support customers. The company’s mobile CT product line will continue to be manufactured in Danvers, Massachusetts in the United States, and will be exported to customers in the EU.
NeuroLogica Corp., the healthcare subsidiary of Samsung Electronics Co., Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography devices. NeuroLogica’s growing portfolio of advanced medical technologies are used worldwide in leading healthcare institutions helping providers enhance patient care, improve patient satisfaction, and increase workflow efficiency. For more information, please visit: http://www.neurologica.com
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