RQMIS
RQMIS (Regulatory/Quality Management Information Source) is a global regulatory consultancy dedicated to guiding medical device, pharmaceutical, nutraceutical, and cosmetic companies through the complex pathways of product development, regulatory approval, and market sustainability. Established in 1996, RQMIS operates from strategic locations in Amesbury, Massachusetts (USA); Barcelona, Spain; and London, United Kingdom, enabling comprehensive support for clients worldwide. RQMIS emphasizes personalized service, ensuring accessibility and responsiveness to client needs. The firm's mission is straightforward: to bring clients' products to market efficiently and maintain their success through ongoing compliance and strategic support.
RQMIS
110 Haverhill Road, Suite # 524, Amesbury, MA, 01913, USA
What We Do
RQMIS provides consulting services for FDA medical device registration and listing, ensuring compliance with FDA regulations and assisting with the Small Business Certification Application.
Expertise in developing regulatory strategies and submissions for medical devices, including 510(k) submissions, PMA applications, and EU MDR compliance.
RQMIS offers clinical study design and management services, ensuring that studies meet regulatory requirements and effectively gather necessary data.
Custom QMS design and compliance services tailored to meet business objectives and regulatory standards, including ISO 13485.
Consulting services for cybersecurity testing and monitoring of medical devices, ensuring compliance with FDA guidelines and protecting against vulnerabilities.
News & Updates
RQMIS will be exhibiting at the MEDICA 2024 Conference in Düsseldorf, Germany from November 11-14, 2024.
Join RQMIS for a webinar on navigating the regulatory application process for medical products on September 11, 2024.
RQMIS will be attending as an exhibitor at The MedTech Conference from October 9-11, 2023, in Anaheim, CA, to meet with existing and prospective clients.
RQMIS is excited to participate in MEDICA 2023, the world's leading international medical trade fair, from November 13-16, 2023, in Düsseldorf, Germany.