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.
Industries
Nr. of Employees
small (1-50)
RQMIS
110 Haverhill Road, Suite # 524, Amesbury, MA, 01913, USA
Products
Medical Device Regulatory Consulting
Design and implement regulatory, clinical, and quality systems strategies to support medical devices, nutraceuticals, cosmetics, and medicines.
EU/UK Authorized Representative Service
Provide representation for non-EU/UK manufacturers to ensure compliance with European and UK medical device regulations.
Medical Device Regulatory Pathway to Market
Address regulatory, clinical, quality, and cybersecurity requirements to bring medical products to market.
Medical Device Development and Validation
Define product's intended use, indication for use, and mechanism of action to determine regulatory impact and compliance.
Medical Device Design Consulting Services
Translate customer requirements into design specifications, create prototypes, and validate designs for regulatory submissions.
Device Master Record (DMR) Consulting
Compile all information necessary to manufacture a medical device, ensuring consistency, quality, and regulatory compliance.
Medical Device Regulatory Consulting
Design and implement regulatory, clinical, and quality systems strategies to support medical devices, nutraceuticals, cosmetics, and medicines.
EU/UK Authorized Representative Service
Provide representation for non-EU/UK manufacturers to ensure compliance with European and UK medical device regulations.
Medical Device Regulatory Pathway to Market
Address regulatory, clinical, quality, and cybersecurity requirements to bring medical products to market.
Medical Device Development and Validation
Define product's intended use, indication for use, and mechanism of action to determine regulatory impact and compliance.
Medical Device Design Consulting Services
Translate customer requirements into design specifications, create prototypes, and validate designs for regulatory submissions.
Device Master Record (DMR) Consulting
Compile all information necessary to manufacture a medical device, ensuring consistency, quality, and regulatory compliance.
Expertise Areas
- Regulatory strategy and premarket submissions (US, EU, UK, international)
- Clinical study design and clinical operations for medical devices and combination products
- Quality management systems design and audit readiness (ISO 13485, FDA QSR)
- Post-market surveillance, complaint handling, and PMCF/registries
Key Technologies
- eTMF and electronic document management systems
- Threat modeling and penetration testing for web/mobile/cloud interfaces
- Static and dynamic code analysis and vulnerability scanning
- Security Information and Event Management (SIEM)
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.
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.