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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Estados Unidos
Inglês
Sobre mim
Medical Device Regulatory & Quality Compliance Expert 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, IEC 62366, ISO 10993, ISO 15223-1, ISO 20417, ISO 11135, ISO 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
Habilidades
Maryam
US$ 100/hora
offline •
Tempo médio de resposta: 1 hora
Conheça meus serviços
Regulamentação de dispositivos médicos
I will implement iso 13485 and prepare your medical device company for certification
Certificação de cibersegurança e TI
I will achieve iso 9001 certification with efficient qms
Quer trabalhar com remuneração por hora?
Diga a Maryam o que você precisa.
US$ 100
/
horaPortfólio
Experiência profissional
Medical Device Regulatory Affairs & Quality Consultant
Expert Medicals • Autônomo
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...
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jaxon_wilde0
Estados Unidos
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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lyra_belrosee
Estados Unidos
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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felixvane
Estados Unidos
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
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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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keal_doyle
Reino Unido
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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