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Radialogica receives European Medical Device Regulation (MDR) certificate and CE marking for its medical software solutions for radiation oncology.
Radialogica’s Quality Management System has been certified to ISO 13485:2003 by SGS North America Inc. SGS also certified Radialogica’s fullAccess™ software product to European Medical Device Directive 93/42/EEC for CE Mark approval. These certifications position Radialogica to significantly strengthen its global market presence.
The MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive (93/42/EEC) and includes more stringent standards and requirements in both clinical and post-market areas. The new Regulation is intended to create a robust, transparent, sustainable and internationally recognized regulatory framework for improved clinical safety and fair market access for manufacturers. The MDR ensures alignment among European member states and is applicable for the entire lifecycle of the products and the processes supporting the solution delivery.
“We’re delighted to celebrate this important milestone for our company and take pride in this recognition of our organizational commitment and capabilities,” said Andrew Cowen, Chief Executive Officer of Radialogica. “As a medical device manufacturer serving the needs of cancer patients and their healthcare providers, Radialogica is dedicated to the highest levels of quality, consistent with international standards and regulatory requirements. Receiving the MDR certificate confirms our compliance with the highest levels of quality and safety and is further evidence of our ongoing commitment to our customers and their patients.”