At ๐๐ ๐ ๐ ๐ฒ๐ฑ๐๐ฒ๐, we are specialized in tailor-made solutions for medical devices, IVDs, MDSW, and AI, prioritizing safety and efficiency. With a customer-specific approach, we guide you through regulatory frameworks, quality systems, and clinical research.
๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ณ๐ณ๐ฎ๐ถ๐ฟ๐ ๐๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐ (๐๐ฉ๐, ๐ ๐, ๐ ๐๐ฆW): we offer encompass device definition and classification, regulatory strategy development, technical documentation elaboration and review, risk analysis according to ISO 14971, and implementation of EU/FDA regulations like MDR, IVDR, 510k, and more. We also cover the implementation of standards like IEC 62304 for medical software, test definition and validation, vigilance systems, post-market surveillance planning, PMCF and PMPF methodologies, economic operator roles management, UDI consulting, and EU MDR/IVDR consultation processes.
๐ค๐๐ฎ๐น๐ถ๐๐ ๐๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐: Development and implementation of QMS according to ISO 13485, ISO 15189, ISO 17025, ISO 9001, GLP, GCP, GCLP. Implementation of QMSR (FDA). GAP analysis. Development and implementation of documentation according to IEC 62304 for MDSW. Internal audits according to ISO 13485, ISO 17025, ISO 15189, GCP, GLP. Management of non-conformities and CAPAs. Liaison with NB and accrediting/certifying bodies.
๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐๐ถ๐ป๐ด: Intended Purpose, labeling, IFU, benefit-risk ratio, CEP/CER, CDP, PEP/PER, SOTA, MDSW/SaMD CER, PMSP/R, PSUR, PMCF/PMPF, SSCP.
๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐: Clinical strategy, feasibility, study design, ethics, authority submissions, data verification, progress reports, monitoring, biostatistics, eCRF, eTMF, ISO assessments.
๐๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐ฎ๐ป๐ฑ ๐ฟ๐ฒ๐ด๐ถ๐๐๐ฟ๐ฎ๐๐ถ๐ผ๐ป: CE Mark & FDA submissions, NB/NCA responses, license completion, device registration, EUDAMED...
๐ง๐ฟ๐ฎ๐ถ๐ป๐ถ๐ป๐ด๐: EU MDR/IVDR, ISO 13485/15189/14971/14155/20916, cybersecurity, usability assessments.
Company Details
- Employees
- 10
- Address
- Madrid, Madrid, Es
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Keywords
- IVD, MD, QMS, ISO 13485, ISO 15189, ISO 17025, ISO 9001, GLP, GCP, GCLP, Medical and clinical writing, Regulatory trainings, CE Mark & FDA submissions, Clinical strategy and documentation.
- HQ
- Madrid, Madrid
Cmg Meddev Questions
Cmg Meddev's LinkedIn profile is https://es.linkedin.com/company/cmgmeddev
Cmg Meddev has
10 employees.
View email and phone details for 10
employees at Cmg Meddev.
Cmg Meddev's industry is
Medical Equipment Manufacturing
Cmg Meddev's categories are Medical Equipment Manufacturing
