Maryam

Medical Device Regulatory Affairs & Quality Consultant

Expert Medicals • Indépendant

Jan 2021 - Present • 5 yrs 6 mos

Provide end-to-end global regulatory, quality, and compliance consulting for medical device manufacturers, importers, distributors, OEM/ODM companies, private label brands, and startups. Support product development from concept to commercialization through regulatory strategy, device classification, intended use review, regulatory pathway assessment, CE Marking, EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820 (QMSR), FDA 510(k), De Novo, PMA, UKCA, MHRA, Health Canada, MDSAP, TGA, SFDA, MOHAP, NMPA, PMDA, CDSCO, HSA, NPRA, Swissmedic, and international market access. Develop and review Technical Documentation, Technical Files, Design Dossiers, Device Master Records, General Safety & Performance Requirements (GSPR), Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Performance Evaluation Reports (PER), Biological Evaluation, Usability Engineering Files, Software Documentation, Cybersecurity Documentation, Labeling, Instructions for Use (IFU), UDI compliance, EUDAMED readiness, Declaration of Conformity, Essential Requirements, and product registration dossiers. Implement and maintain ISO 13485 Quality Management Systems, ISO 14971 Risk Management, IEC 62304, IEC 62366-1, ISO 10993 Series, ISO 15223-1, ISO 20417, ISO 11135, ISO 11137, ISO 11607, ISO/TR 24971, ISO 14155, ISO 14644, and applicable EN, IEC, ASTM, AAMI, IMDRF, MDCG, MEDDEV, and FDA guidance documents. Conduct gap assessments, internal audits, supplier audits, design control reviews, CAPA implementation, change control, validation support, complaint handling, post-market surveillance (PMS), PMCF, vigilance, PSUR preparation, management reviews, risk assessments, Notified Body audit preparation, FDA inspection readiness, MDSAP readiness, and certification support. Support Class I, Class II, Class III, reusable and sterile medical devices, IVDs, SaMD, AI-enabled medical devices, surgical and dental instruments, orthopedic, cardiovascular, rehabilitation, diagnostic, wound care...