Regulatory Compliance Info


Quality Management System

ISO 13485 quality system certification

Cell Marque meets and/or exceeds the standards for ISO 13485, an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of medical devices.

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US FDA Good Manufacturing Practice (GMP)

We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations

View our Establishment Registration on the FDA website


Medical Device Manufacturing License

California State Medical Device Manufacturing License

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Product Certifications and Approvals

Europe - Declarations of Conformity
Direct Product:
PDF
Ventana Product:
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Global Regulatory Representatives

Shown below are our in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here.


EUROPE - Authorized Representative

Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570
Emergo Europe Website