Press Release

Rinicare awarded ISO 13485 certification

Rinicare has been certified to the internationally-recognised Quality Management System medical device standard, ISO 13485:2016.

Rinicare has announced today that it has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. Certification to the standard is considered a de facto requirement for almost all regulatory purposes internationally, and represents an important milestone on the company’s journey.

ISO 13485:2016 certification required a rigorous 3-day audit and covered all aspects of quality management. Certification was issued by SGS United Kingdom Limited, part of the world’s leading testing, inspection and certification company.

Dr Anthony Holmes, Managing Director for Rinicare, commented, “The implementation and certification of the company’s quality management system to ISO 13485 represents an enormous achievement for the team and is represents a significant milestone for the company. It reflects the razor-sharp focus that we’ve always had on producing safe, innovative products that make a real difference to our users, and I’m delighted to see our hard work recognised.”