INTERNATIONAL
REGULATORY
COMPLIANCE

Rook QS will work to help your company achieve international device approval including CE Mark, Health Canada, China, Australia, and other markets through on-site audit support and regulatory communication.

PARTNER AND GROW WITH THE EXPERTS

We are a consulting firm dedicated to helping medical device companies develop and maintain effective and efficient quality systems. We provide specialized and custom consulting services for all classes of medical devices including Software as a Medical Device (SaMD).

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