Quality and Regulatory

GRAIL has implemented robust policies and procedures for the development and manufacture of regulated medical products. GRAIL has received the following  certifications as it demonstrates compliance with international quality and patient/user standards – 

Quality Management Systems – Medical Device

• ISO 13485:2016 Medical Devices – QMS Requirements for regulatory purposes (Menlo Park, CA and Research Triangle Park, NC)

Quality Management Systems – Clinical Laboratories

• ISO 15189:2012 Medical Laboratories – Requirements for quality and competence (Menlo Park, CA and Research Triangle Park, NC)

Privacy and Security Information Management Systems

• ISO 27001:2013 Information Security Management System Certificate (Menlo Park, CA)

Clinical Laboratory – Licenses and Certifications

Menlo Park, CA Clinical Laboratory

• CLIA Certificate of Accreditation: 05D2154430
• The College of American Pathologists (CAP): 8149563
• California Department of Public Health: CDF-00352665
• Maryland Department of Health Permit: 3204
• Rhode Island Department of Health License: LCO01503
• New York State Department of Health Permit: PFI-9558
• Pennsylvania Department of Health Permit: 38399

Research Triangle Park (RTP), NC

• CLIA Certificate of Accreditation: 34D2231294
• The College of American Pathologists (CAP): 9151388
• California Department of Public Health: CDS-90007074
• Maryland Department of Health Permit: 3526
• Rhode Island Department of Health License: LCO01562
• New York State Department of Health Permit: PFI-9711
• Pennsylvania Department of Health Permit: 39687