Doing or planning to do business outside of the US? Visit our sister companies. RQMIS AR LTD. or RQMIS EU SL More

Integrating regulatory, clinical and quality requirements with medical product lifecycle success.

Trust RQMIS with designing and implementing the regulatory, clinical and quality systems strategy to support your medical product idea. We know what it takes to get your idea to market and keep it there.

RQMIS provides therapeutically focused, comprehensive, regulatory consultation to the global medical device and the combination product industries.

The regulatory consultancy is focused in three principle areas:

RQMIS was established in 1996 and provides medical device and biotechnology manufacturers with strategic guidance on how to effectively navigate the FDA and EU regulations specific to medical devices and combination products. RQMIS personnel has worked both at the Office of Device Evaluation/CDRH/FDA and in the field for the FDA.

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