The Belgium based medical device company, Novosanis, was audited by SGS Belgium (Société Generale de Surveillance) to thoroughly assess its quality management system for the design, development, manufacture and distribution of its two medical devices Colli-PeeTM, a urine collection device and VAX-IDTM, an intradermal injection device.
During the assessment by SGS, Novosanis demonstrated to meet all the requirements of the ISO13485:2003 and ISO13458:2012 quality standards. This has led to the official certification by the notified body SGS.
“Receiving the ISO13485 certificate is a true reward for the team’s effort and commitment to produce both platforms, Colli-Pee and VAX-ID, according to best practice. It is an objective recognition that allows customers and stakeholders to gain trust in what the Novosanis team offers which is very motivating for the entire team.” said Timothi Van Mulder, Quality Manager at Novosanis.