MERIT is ISO 13485 certified to provide imaging services to global pharmaceutical, biotechnology, medical device, and CROs that are conducting clinical trials. Our ISO 13485 certified Quality Management System (QMS) has been designed to:
Our QMS includes technical and procedural controls that reflect not only ISO 13485, but also 21 CFR Part 820 Quality System Regulation, ICH E6 (R2), and GxP industry standards.
Our ISO 13485 certification validates our ability to provide imaging services that consistently meet customer and regulatory requirements applicable specifically to medical devices.
MERIT CRO’s certification has been assessed by NSF-International Strategic Registrations (NSF-ISR) and found to be in conformance with ISO 13485.