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Nederlands
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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Verenigde Staten
Engels
Over mij
Global Medical Device Regulatory & Digital Health Compliance Partner specializing in EU MDR 2017/745, IVDR, CE Marking, UKCA, MHRA, FDA 21 CFR 820/QMSR, FDA 510(k), PMA, De Novo, ISO 13485, ISO 14971, IEC 62304, 62366, ISO 10993, ISO 15223-1, ISO 20417, ISO 11135, 11137, MDSAP, Health Canada, TGA, SFDA, MOHAP, NMPA, PMDA, CDSCO, EUDAMED, UDI, GSPR, CER, CEP, PER, PMS, PMCF, PSUR, Clinical & Performance Evaluation, Technical Documentation, Design Dossier, Risk Management, Usability Engineering, Biocompatibility, Sterilization, QMS, Internal Audits, Global Regulatory Submissions & Market Access
Skills
Maryam
US$ 100/uur
offline •
Gemiddelde reactietijd: 1 uur
Bekijk mijn diensten
Regelgeving voor medische hulpmiddelen
I will implement iso 13485 and prepare your medical device company for certification
IT- en cyberbeveiligingscertificering
I will achieve iso 9001 certification with efficient qms
Wil je op uurbasis werken?
Vertel Maryam wat je nodig hebt.
US$ 100
/
uurPortfolio
Werkervaring
Medical Device Regulatory Affairs, Quality & Digital Health Compliance Consultant
Expert Medicals • ZZP
Jan 2021 - Present • 5 yrs 7 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.
165 Reviews
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keal_doyle
Verenigd Koninkrijk
Maryam provided exceptional support throughout our SFDA compliance project. Her knowledge of Saudi regulatory requirements, medical device documentation, and submission processes was impressive. She carefully reviewed our documents, identified critical gaps, and provided clear guidance on how to meet SFDA requirements.
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lyra_belrosee
Verenigde Staten
Excellent experience working with Maryam. She demonstrated strong knowledge of ISO 9001 requirements and provided practical, well-structured guidance that was easy to understand and implement. Communication was professional, responsive, and timely throughout the project. The deliverables were detailed,...
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jaxon_wilde0
Verenigde Staten
Very good work! The quality management documents were created in a clean and professional way. Everything was reliable and well structured. You can clearly see that he truly loves his work and is very committed. Highly recommended! 👍
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felixvane
Verenigde Staten
She demonstrated exceptional expertise in ISO 13485 and medical device quality management systems. The guidance provided was practical, well-structured, and reflected genuine hands-on experience with regulatory compliance and certification preparation.
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rushingstan
Verenigde Staten
Maryam was extremely knowledgeable and professional throughout the project. She clearly explained the CE, FDA, and UKCA requirements for our medical devices and provided practical guidance on the regulatory pathway. Communication was excellent, deliverables were well organized, and all questions were...
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