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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Estados Unidos
Inglés
Sobre mí
Medical Devices Regulatory & Compliance Expert with extensive experience in international standards, regulations, directives, and guidelines for the medical device industry. Specialized in EU MDR, CE Marking, ISO 13485, ISO 14971, FDA 21 CFR 820, UKCA, MHRA, SFDA, TGA, EUDAMED, EC REP, and global market access requirements. Services include regulatory strategy, technical documentation, QMS implementation, regulatory submissions, audits, risk management, CE/FDA support, and post-market surveillance assistance.
Habilidades
Maryam
USD 100/hora
desconectado •
Tiempo medio de respuesta: 1 hora
Revisa mis servicios
Reglamentos para dispositivos médicos
I will implement iso 13485 and prepare your medical device company for certification
Certificación de TI y ciberseguridad
I will achieve iso 9001 certification with efficient qms
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USD 100
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horaPorfolio
165 Reseñas
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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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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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felixvane
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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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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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rushingstan
Estados Unidos
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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