RQMIS (Regulatory/Quality Management Information Source)
Business-Consulting-and-Services
Website
Company Tagline
We integrate Regulatory, Clinical and Quality requirements with global medical product lifecycle success.
Industry Category
Business Keywords
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
Compare Companies Side by Side
Compare RQMIS (Regulatory/Quality Management Information Source) with 3 companies in Business-Consulting-and-Services
| Comparison Field |
RQMIS (Regulatory/Quality...Main Company |
MEDIcept Inc.View Profile |
Red MedtechView Profile |
REAF ConsultingView 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 Companies1996
Oldest Founded2
Countries83
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Alternative Company Names
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