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, combination product and pharmaceutical industries.

The regulatory consultancy is focused in three principle areas:

What is RQMIS?

RQMIS stands for "Regulatory/Quality Management Information Source". We were established in the US in 1996 and provide our clients with strategic guidance on how to effectively navigate the FDA and EU regulations specific to medical devices, combination products, pharmaceuticals, AI and Machine Learning products, among others. Our team of consultants is led by a former FDA reviewer from the Office of Device Evaluation, Boston district.

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