Certification of the quality management system for medical devices is an important step towards global market roll-out.
Utrecht, October 15th, 2019 – In the past half year, MRIguidance has had its quality management system reviewed by the notified body Dare Medical Certifications. Today, the auditors have confirmed the quality system follows all required regulation in order to be certified.
“We have worked very hard for this.” says Roel Raatgever, CEO of MRIguidance, “and importantly not only the quality assurance officer and the management team, but every employee of MRIguidance has been fully committed to achieving this milestone. I am very proud of the progress we have made since the beginning of this year.”
A quality management system is a requirement for market approval of medical devices. With the ISO 13485 certification, a medical device company ensures it complies with regulation in most countries.