GRAIL has received formal ISO 13485 certification from BSI, our EU Notified Body, for its Quality Management System. This certification applies to both of GRAIL’s sites, located in Menlo Park, CA and Durham, NC. Receiving ISO 13485 certification indicates that GRAIL has implemented robust policies and procedures for the development and manufacture of regulated medical products. 

This certification is a critical step forward for GRAIL, as it demonstrates compliance with international quality and patient/user standards.