SOFTWARE
VALIDATION

Rook Consultants can provide validation and testing strategies and support for the software.  Including SaMD, apps, and QMS software to ensure Regulatory Compliance with ISO 13485:2016, IEC 62034/82304, and IEC 60601.

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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).

BOOK MEETING

In Meeting