RQMIS (Regulatory/Quality Management Information Source)

RQMIS (Regulatory/Quality Management Information Source)

Business-Consulting-and-Services

Amesbury, MA
United States
Company Tagline

We integrate Regulatory, Clinical and Quality requirements with global medical product lifecycle success.

Industry Category
Business-Consulting-and-Services
Company Description

RQMIS (Regulatory/Quality Management Information Source) is a premier business consulting and services company dedicated to ensuring the global medical product lifecycle's success through integrated regulatory, clinical, and quality requirements. With strategically located offices, including the primary location at 110 Haverhill Road, Suite 526, Amesbury, MA 01913, US, RQMIS is well-positioned to deliver exceptional service worldwide. RQMIS helps businesses navigate the complexities of the medical device, pharmaceutical, nutraceutical, and cosmetic industries.

The company's commitment to excellence and comprehensive support empowers clients to bring innovative products to market efficiently and maintain compliance. RQMIS offers a one-stop-shop for integrated, personalized services, optimizing quality management systems and streamlining clinical trials. RQMIS specializes in regulatory strategy, clinical evaluation reports (CER), FDA pre-submission, EU MDR/IVDR, and post-market surveillance, ensuring clients stay ahead in a rapidly evolving industry.

RQMIS is your trusted partner for regulatory navigation and compliance. Its expert team is ready to guide businesses through every step of the process, ensuring seamless navigation of FDA, EU, and UK requirements. RQMIS enhances sales potential and commercial development for its clients. We invite the company's management to create a customized and exclusive company showcase and product listing on our platform to further amplify their market presence.

RQMIS (Regulatory/Quality Management Information Source) est une entreprise de premier plan dans le domaine du conseil et des services aux entreprises, dédiée à assurer le succès du cycle de vie mondial des produits médicaux grâce à des exigences réglementaires, cliniques et de qualité intégrées. Avec des bureaux stratégiquement situés, notamment l'adresse principale au 110 Haverhill Road, Suite 526, Amesbury, MA 01913, États-Unis, RQMIS est bien positionnée pour fournir un service exceptionnel dans le monde entier. RQMIS aide les entreprises à naviguer dans les complexités des industries des dispositifs médicaux, des produits pharmaceutiques, des produits nutraceutiques et des cosmétiques.

L'engagement de l'entreprise envers l'excellence et un soutien complet permet aux clients de mettre sur le marché des produits innovants de manière efficace et de maintenir la conformité. RQMIS offre un guichet unique pour des services intégrés et personnalisés, optimisant les systèmes de gestion de la qualité et rationalisant les essais cliniques. RQMIS se spécialise dans la stratégie réglementaire, les rapports d'évaluation clinique (CER), la pré-soumission à la FDA, l'EU MDR/IVDR et la surveillance post-commercialisation, garantissant ainsi à ses clients de rester à la pointe dans un secteur en évolution rapide.

RQMIS est votre partenaire de confiance pour la navigation réglementaire et la conformité. Son équipe d'experts est prête à guider les entreprises à chaque étape du processus, assurant une navigation fluide des exigences de la FDA, de l'UE et du Royaume-Uni. RQMIS améliore le potentiel de vente et le développement commercial de ses clients. Nous invitons la direction de l'entreprise à créer une vitrine d'entreprise et une liste de produits personnalisées et exclusives sur notre plateforme afin d'amplifier davantage leur présence sur le marché.

Key Personnel / Employees
Frank Manning III Ari Sobel Barry Sands Karol-Anne O'Leary

Compare Companies Side by Side

Compare RQMIS (Regulatory/Quality Management Information Source) with 3 companies in Business-Consulting-and-Services

4 Companies
Comparison Field
RQMIS (Regulatory/Quality Management Information Source)
RQMIS (Regulatory/Quality...
Main Company
MEDIcept Inc.
MEDIcept Inc.
View Profile
Red Medtech
Red Medtech
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REAF Consulting
REAF Consulting
View Profile
Founded Year
1996 2017 2007
Company Size
11-50 2-10 2-10
City
Amesbury, MA Boston, MA Swansea, UK Centurion, Gauteng
Country
United States United States South Africa
Skills & Keywords Comparing with main company
28 Total Skills
Regulatory Consulting Medical Device Compliance Quality Management Systems Clinical Trials FDA Regulations EU MDR IVDR Insurance Reimbursement EU Authorized Representative Regulatory Clinical Evaluation Report (CER) Consulting Clinical Trial Design FDA Presubmission EU MDR / IVDR Product Classification 510(k) Regulatory Strategy Post-Market Surveillence Techincal Files FDA Clearance FDA Consulting De Novo Medical Devices Clinical US Agent Audits UK Responsible Person
24 Total 24 Unique
Unique Skills:
483 / Warning Letter CAPA Clinical Research Organization CRO Cybersecurity Design Control +18
18 Total 1 Common 17 Unique
Match 4%
Common Skills:
EU MDR
Unique Skills:
CE mark projects Compliance Consultancy Design Assurance Design History Files Development +11
18 Total 18 Unique
Unique Skills:
Asset managment Asset Register Recording Clinical Engineering Clinical Planning Commissioning Cumputerised Maintenance Management Systems +12
4
Total Companies
1996
Oldest Founded
2
Countries
83
Unique Skills

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Alternative Company Names

This company is also known as

RQMIS (Regulatory/Quality Management Information Source) RQMIS(法规/质量管理信息来源) RQMIS (नियामक/गुणवत्ता प्रबंधन सूचना स्रोत) RQMIS (Fuente de información de gestión regulatoria/calidad) RQMIS (مصدر معلومات التنظيم/إدارة الجودة) RQMIS (Source d'informations sur la réglementation/gestion de la qualité) RQMIS (Источник информации по регулированию/управлению качеством) RQMIS (Fonte de Informação de Gestão Regulatória/Qualidade)