ISO 13485:2016 Certification

ISO 13485 in an internationally agreed standard that specifies requirements for a quality management systems (QMS) within companies that provide medical devices and related services.

These systems establish and maintain the effectiveness of processes. It ensures the consistent design, development, production, installation, and delivery of medical devices which are safe for their intended purpose.

Certification to ISO 13485 is awarded to companies by accredited bodies, such as the globally recognised BSI group, known for its expertise and its prestigious Royal Chartership.

In April 2020 BSI certified Apis Assay Technologies Ltd as operating a QMS which complies with the requirements of ISO 13485 for the design and development of in vitro molecular diagnostic assays for detection of biomarkers linked to various human diseases and their therapy.