ISO Certification for Bellus Medical

Bellus Medical, the maker of SkinPen, has been awarded the International Organisation for Standardisation (ISO) 13485:2016 certification.

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

“The ISO 13485:2016 certification proves the strength of our organisation, demonstrates our commitment to quality, and builds our customers’ confidence as their trusted partner,” said Joe Proctor, Bellus Medical president and CEO. “I’m proud to recognise this significant milestone for our company, making Bellus Medical the only microneedling provider to meet the ISO 13485:2016 standards.”