ISO 13485 Certified for Medical Device Trials

ISO 13485 Certified Imaging Core Lab

ISO Certified Medical Imaging Core Lab

Intrinsic Imaging is ISO 13485 certified to provide Imaging Core Lab Services for Phase I-IV Clinical Trials and Class I,II, III Medical Device Trials.

While all companies state they are committed to quality, only Intrinsic Imaging has the most comprehensive and sophisticated quality management system in the industry.

Our quality management system is FDA audited, ISO 9001, ISO 13485, ISO 22301 and ISO 27001 certified and GAMP® 5 compliant.

Most noteworthy to our Sponsors, Intrinsic Imaging ISO certified quality management systems enables us to conduct trials with unmatched operational excellence to ensure on time quality results.

ISO 13485 Certified

Our ISO 13485 Quality Management System is specifically for providing imaging core lab services for Class I, II and III Medical Device trials in support of 510(k) and Pre-Market Notifications.

Intrinsic Imaging’s ISO 13485 certification demonstrates our ability to provide imaging core lab services that consistently meet customer and regulatory requirements applicable specifically to medical devices.

Applicable to all Medical Devices

Certified by the British Standards Institute (BSI), Intrinsic Imaging’s ISO 13485 quality certification is applicable across the entire organization for all Medical Devices.

Angioplasty balloons
Biologics
Biopsy Equipment
Catheters
Diagnostic software
Drug Delivery Devices
Embolization
Filters
Novel devices
Stents
Thrombectomy devices
Venous access tools
Wires