CMG MedDev

At 𝗖𝗠𝗚 𝗠𝗲𝗱𝗗𝗲𝘃, 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. 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀 (𝗜𝗩𝗗, 𝗠𝗗, 𝗠𝗗𝗦W): 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. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀: 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. 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝘄𝗿𝗶𝘁𝗶𝗻𝗴: Intended Purpose, labeling, IFU, benefit-risk ratio, CEP/CER, CDP, PEP/PER, SOTA, MDSW/SaMD CER, PMSP/R, PSUR, PMCF/PMPF, SSCP. 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀: Clinical strategy, feasibility, study design, ethics, authority submissions, data verification, progress reports, monitoring, biostatistics, eCRF, eTMF, ISO assessments. 𝗔𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗮𝗻𝗱 𝗿𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻: CE Mark & FDA submissions, NB/NCA responses, license completion, device registration, EUDAMED... 𝗧𝗿𝗮𝗶𝗻𝗶𝗻𝗴𝘀: EU MDR/IVDR, ISO 13485/15189/14971/14155/20916, cybersecurity, usability assessments.