BaxMed Regulatory Ltd
Business-Consulting-and-Services
Website
Company Tagline
Medical device and IVD Regulatory Affairs, Clinical Affairs & Quality Assurance Consultancy services
Industry Category
Business Keywords
Company Description
BaxMed Regulatory Ltd specializes in providing comprehensive business consulting and services, particularly in the highly regulated field of medical devices and in-vitro diagnostics (IVD). Located in Leeds, West Yorkshire, BaxMed Regulatory Ltd offers expert consultancy services designed to ensure regulatory compliance and market access for its clients.
BaxMed Regulatory Ltd excels in several key areas, including Medical Device Regulatory Affairs, In Vitro Diagnostic Regulatory Affairs, and Quality Management according to ISO 13485:2016 standards. The company provides crucial support for Risk Management (ISO 14971:2019), EU, UK, US, APAC, and LATAM device registrations. BaxMed Regulatory Ltd also delivers exceptional services in Clinical Affairs and Technical Documentation, offering strategic regulatory guidance, device classification, and thorough evaluation reports.
With a commitment to excellence, BaxMed Regulatory Ltd is dedicated to helping businesses navigate the complexities of regulatory landscapes. The primary address for BaxMed Regulatory Ltd is in Leeds, West Yorkshire, GB. We invite the management team at BaxMed Regulatory Ltd to create a customized and exclusive company showcase and product listing on our platform to further enhance their market presence.
BaxMed Regulatory Ltd est spécialisée dans la fourniture de services de conseil aux entreprises complets, en particulier dans le domaine très réglementé des dispositifs médicaux et des diagnostics in vitro (DIV). Située à Leeds, West Yorkshire, BaxMed Regulatory Ltd offre des services de conseil spécialisés conçus pour garantir la conformité réglementaire et l'accès au marché pour ses clients.
BaxMed Regulatory Ltd excelle dans plusieurs domaines clés, notamment les affaires réglementaires des dispositifs médicaux, les affaires réglementaires des diagnostics in vitro et la gestion de la qualité conformément aux normes ISO 13485:2016. L'entreprise fournit un soutien essentiel pour la gestion des risques (ISO 14971:2019), les enregistrements de dispositifs dans l'UE, au Royaume-Uni, aux États-Unis, en APAC et en LATAM. BaxMed Regulatory Ltd fournit également des services exceptionnels dans les domaines des affaires cliniques et de la documentation technique, offrant des conseils stratégiques en matière de réglementation, la classification des dispositifs et des rapports d'évaluation approfondis.
Avec un engagement envers l'excellence, BaxMed Regulatory Ltd se consacre à aider les entreprises à naviguer dans la complexité des environnements réglementaires. L'adresse principale de BaxMed Regulatory Ltd est à Leeds, West Yorkshire, GB. Nous invitons l'équipe de direction de BaxMed Regulatory Ltd à créer une vitrine d'entreprise et une liste de produits personnalisées et exclusives sur notre plateforme afin d'améliorer encore leur présence sur le marché.
Key Personnel / Employees
Compare Companies Side by Side
Compare BaxMed Regulatory Ltd with 3 companies in Business-Consulting-and-Services
| Comparison Field |
BaxMed Regulatory LtdMain Company |
AIXIAL GROUPView Profile |
Wego Chemical GroupView Profile |
Regulatus LtdView Profile |
|---|---|---|---|---|
|
Founded Year
|
— | 1978 | 2017 | |
|
Company Size
|
— | 1,001-5,000 | 51-200 | 2-10 |
|
City
|
Leeds, West Yorkshire | Boulogne-Billancourt, Ile de France | Great Neck, New York | Shepton Mallet, England |
|
Country
|
United Kingdom | France | United States | |
|
Skills & Keywords
Comparing with main company
|
24 Total Skills
Medical Device Regulatory Affairs
In Vitro Diagnostics
ISO 13485
Risk Management
Clinical Affairs
Technical Documentation
Device Registration
Clinical Evaluation
quality assurance
device registration
Performance Evaluation
EU IVDR
in vitro diagnostics
IVD
global device registration
clinical affairs
technical files
medical devices
510(k)
US FDA
iso 13485:2016
UKCA
EU MDR
regulatory affairs
|
17 Total
17 Unique
Unique Skills:
ATU
Biometrics & Clinical Research
biostatistics
biotechs
clinical trials
Contract Research Organisation
+11
|
3 Total
3 Unique
Unique Skills:
chemical distribution
chemicals
supply chain management
|
4 Total
4 Unique
Unique Skills:
Design for Sterility
ISO13485
IVDD
UKRP
|
4
Total Companies1978
Oldest Founded3
Countries48
Unique SkillsSimilar Companies
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Alternative Company Names
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