Maryam

Medical Device Regulatory Affairs, Quality & Digital Health Compliance Consultant

Expert Medicals • Selbstständig

Jan 2021 - Present • 5 yrs 9 mos

Provide end-to-end global regulatory, quality, cybersecurity, privacy, and compliance consulting for medical device manufacturers, IVD manufacturers, Software as a Medical Device (SaMD) developers, AI-enabled medical device companies, digital health organizations, healthcare software providers, 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. Provide information security, privacy, and compliance consulting including ISO/IEC 27001, ISO/IEC 27017, ISO/IEC 27018, ISO/IEC 27701, ISO/IEC 20000-1, ISO/IEC 22301, ISO/IEC 42001, SOC 2 Type I & II, HIPAA, HITRUST, PCI DSS 4.0, NIST Cybersecurity Framework (CSF), NIST SP 800-53, CIS Controls, GDPR, Saudi PDPL, UAE Personal Data Protection Law, AI governance, cloud security, and digital compliance frameworks. 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 Reports (BER), Usability Engineering Files, Software Documentation, Software Development Lifecycle (SDLC) documentation, Secure Development documentation, Cybersecurity Risk Management Files, Threat Modeling, Software Bill of Materials (SBOM), Vulnerability Management documentation, Labeling, Instructions for Use (IFU), UDI compliance, EUDAMED readiness, Declaration of Conformity, Essential Requirements, technical dossiers, cybersecurity privacy, and global market access solutions from concept through commercialization.