RQMIS, Inc.
RQMIS is a global consulting firm specializing in regulatory, clinical, quality, and cybersecurity services for the medical device, pharmaceutical, nutraceutical, and cosmetic industries. Since 1996, it has supported clients worldwide with a focus on bringing innovative products to market and ensuring they remain there through comprehensive strategies and expert guidance. With offices in Boston, USA; Barcelona, Spain; and London, UK, RQMIS offers tailored solutions in regulatory strategy, clinical study management, quality systems, and cybersecurity, among others. The company emphasizes personalized service, industry expertise, and a strong international presence to help clients navigate complex regulatory landscapes and achieve market success.
Industries
Nr. of Employees
small (1-50)
RQMIS, Inc.
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.
Services
Regulatory strategy, submission preparation (510(k), De Novo, PMA, IDE), regulatory negotiations and market access planning across US, EU, UK, and Canada.
Protocol development, clinical trial management, monitoring, clinical evaluation reports, PMCF studies, DSMB setup, and bioresearch monitoring.
QMS design and implementation (ISO 13485, FDA QSR), internal audits, audit remediation, CAPA development, and MDSAP support.
Penetration testing for web and mobile applications, cybersecurity planning, SIEM recommendations, and SOC support for detection and incident response.
Management of complaints, vigilance reporting, trend analysis, PMCF studies, and technical documentation updates for continued compliance.
Provision of EU Authorized Representative and UK Responsible Person functions including registration, document retention, and liaison with authorities.
Regulatory strategy, submission preparation (510(k), De Novo, PMA, IDE), regulatory negotiations and market access planning across US, EU, UK, and Canada.
Protocol development, clinical trial management, monitoring, clinical evaluation reports, PMCF studies, DSMB setup, and bioresearch monitoring.
QMS design and implementation (ISO 13485, FDA QSR), internal audits, audit remediation, CAPA development, and MDSAP support.
Penetration testing for web and mobile applications, cybersecurity planning, SIEM recommendations, and SOC support for detection and incident response.
Management of complaints, vigilance reporting, trend analysis, PMCF studies, and technical documentation updates for continued compliance.
Provision of EU Authorized Representative and UK Responsible Person functions including registration, document retention, and liaison with authorities.
Expertise Areas
- Regulatory strategy and submissions (US, EU, UK, Canada)
- Clinical trial design and management (Phase II/III and PMCF)
- Quality management systems and ISO 13485/QSR compliance
- Postmarket surveillance and vigilance
Key Technologies
- Software as a Medical Device (SaMD)
- Machine learning / artificial intelligence
- 3D printing (additive manufacturing) for implants
- Cloud-based platform and IoT connectivity
News & Updates
RQMIS will offer specialized training classes through the Workforce Training Fund Program (WTFP) Express Program, supported by the Commonwealth Corporation, starting July 1, 2025. These courses aim to enhance regulatory and quality expertise for Massachusetts businesses.
An overview of the upcoming regulatory requirements for medical devices, focusing on the De Novo pathway and eSTAR compliance, with a deadline of October 2025.
Analysis of potential impacts on the medical device industry if the FDA's regulatory processes are disrupted or collapse.
Guidance on software qualification under the In Vitro Diagnostic Regulation (IVDR), including insights from the Notified Bodies.
A comprehensive guide to the Premarket Approval (PMA) process for Class III medical devices, including tips for successful navigation.
Discussion on the cybersecurity challenges posed by AI-enabled medical devices and strategies to mitigate risks.
RQMIS will offer specialized training classes through the Workforce Training Fund Program (WTFP) Express Program, supported by the Commonwealth Corporation, starting July 1, 2025. These courses aim to enhance regulatory and quality expertise for Massachusetts businesses.
An overview of the upcoming regulatory requirements for medical devices, focusing on the De Novo pathway and eSTAR compliance, with a deadline of October 2025.
Analysis of potential impacts on the medical device industry if the FDA's regulatory processes are disrupted or collapse.
Guidance on software qualification under the In Vitro Diagnostic Regulation (IVDR), including insights from the Notified Bodies.
A comprehensive guide to the Premarket Approval (PMA) process for Class III medical devices, including tips for successful navigation.
Discussion on the cybersecurity challenges posed by AI-enabled medical devices and strategies to mitigate risks.