CMG MedDev
Medical-Equipment-Manufacturing
Company Tagline
A tailored MD/IVD consulting service that helps you to bring your product to the market, from your idea to the patients.
Industry Category
Business Keywords
Company Description
CMG MedDev is a leading provider of tailored solutions in the medical device and IVD (In Vitro Diagnostics) sectors, dedicated to ensuring the safety and efficiency of medical products from concept to market. CMG MedDev specializes in offering customer-specific guidance through regulatory frameworks, quality systems, and clinical research, enabling clients to navigate the complexities of the medical device industry with confidence. The company’s comprehensive services cover a broad spectrum of needs, including device definition and classification, regulatory strategy development, technical documentation, risk analysis, and the implementation of EU/FDA regulations such as MDR, IVDR, and 510k.
Located in Madrid, Spain, CMG MedDev excels in the development and implementation of Quality Management Systems (QMS) according to ISO 13485, ISO 15189, ISO 17025, ISO 9001, GLP, and GCP standards. The company also provides essential medical writing services, covering intended purpose documentation, labeling, IFUs, benefit-risk ratios, and clinical evaluation reports. Furthermore, CMG MedDev offers expert clinical services, including clinical strategy development, feasibility studies, study design, ethics submissions, data verification, and biostatistics.
With a focus on approvals and registrations, CMG MedDev supports clients through CE Mark and FDA submissions, NB/NCA responses, license completion, device registration, and EUDAMED processes. The company also provides specialized training in EU MDR/IVDR, ISO 13485/15189/14971/14155/20916, cybersecurity, and usability assessments. CMG MedDev operates primarily out of its Madrid headquarters. We invite the management of CMG MedDev to create a customized and exclusive company showcase and product listing on our platform to further enhance their market presence.
CMG MedDev's primary address is in Madrid, Spain.
CMG MedDev es un proveedor líder de soluciones personalizadas en los sectores de dispositivos médicos y DIV (Diagnóstico In Vitro), dedicado a garantizar la seguridad y la eficiencia de los productos médicos desde el concepto hasta el mercado. CMG MedDev se especializa en ofrecer orientación específica al cliente a través de marcos regulatorios, sistemas de calidad e investigación clínica, lo que permite a los clientes navegar con confianza por las complejidades de la industria de dispositivos médicos. Los servicios integrales de la empresa cubren un amplio espectro de necesidades, incluida la definición y clasificación de dispositivos, el desarrollo de estrategias regulatorias, la documentación técnica, el análisis de riesgos y la implementación de regulaciones de la UE/FDA como MDR, IVDR y 510k.
Ubicada en Madrid, España, CMG MedDev destaca en el desarrollo e implementación de Sistemas de Gestión de Calidad (SGC) según las normas ISO 13485, ISO 15189, ISO 17025, ISO 9001, GLP y GCP. La empresa también proporciona servicios esenciales de redacción médica, que cubren la documentación del propósito previsto, el etiquetado, las IFU, las relaciones beneficio-riesgo y los informes de evaluación clínica. Además, CMG MedDev ofrece servicios clínicos expertos, incluido el desarrollo de estrategias clínicas, estudios de viabilidad, diseño de estudios, presentaciones de ética, verificación de datos y bioestadística.
Con un enfoque en aprobaciones y registros, CMG MedDev apoya a los clientes a través de presentaciones de la Marca CE y la FDA, respuestas NB/NCA, finalización de licencias, registro de dispositivos y procesos EUDAMED. La empresa también ofrece capacitación especializada en EU MDR/IVDR, ISO 13485/15189/14971/14155/20916, ciberseguridad y evaluaciones de usabilidad. CMG MedDev opera principalmente desde su sede en Madrid. Invitamos a la dirección de CMG MedDev a crear una presentación de empresa y un listado de productos personalizados y exclusivos en nuestra plataforma para mejorar aún más su presencia en el mercado.
La dirección principal de CMG MedDev se encuentra en Madrid, España.
Key Personnel / Employees
Compare Companies Side by Side
Compare CMG MedDev with 3 companies in Medical-Equipment-Manufacturing
| Comparison Field |
CMG MedDevMain Company |
QUALITY ACADEMYView Profile |
Certvalue - Global C...View Profile |
Eurofins BioPharma P...View Profile |
|---|---|---|---|---|
|
Founded Year
|
— | 2010 | 2017 | 1971 |
|
Company Size
|
— | 2-10 | 51-200 | 201-500 |
|
City
|
Madrid, Madrid | Bengaluru, Karnataka | Vimodrone, (MI) | |
|
Country
|
Spain | India | ||
|
Skills & Keywords
Comparing with main company
|
19 Total Skills
Medical Devices
IVD
Regulatory Affairs
Quality Management Systems
Clinical Research
Medical Writing
ISO 13485
Medical & clinical writing
MD
Regulatory trainings
ISO 9001
GLP
GCLP
ISO 17025
GCP
CE Mark & FDA submissions
Clinical strategy & documentation
ISO 15189
QMS
|
18 Total
18 Unique
Unique Skills:
Auditing Training
Certification Audits
CQI & IRCA Approved Programs
Energy Management
Environmental Management
Food Safety
+12
|
18 Total
18 Unique
Unique Skills:
BIFMA
CE Mark
GAP
GMP
HACCP
ISO 14001
+12
|
12 Total
12 Unique
Unique Skills:
Biocide Testing
BioPharmaceutical Testing
Cosmetic Testing
FDA INSPECTED
GMP
ISO 22716
+6
|
4
Total Companies1971
Oldest Founded2
Countries61
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Alternative Company Names
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