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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Stati Uniti
Inglese
Chi sono
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.
Competenze
Maryam
100 USD/ora
offline •
Tempo di risposta medio: 1 ora
Consulta i miei servizi
Regolamentazione per dispositivi medici
I will implement iso 13485 and prepare your medical device company for certification
Certificazione IT e Cybersecurity
I will achieve iso 9001 certification with efficient qms
Vuoi lavorare su base oraria?
Spiega a Maryam cosa ti serve.
100 USD
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oraPortfolio
165 Recensioni
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1-5 di 165 recensioni
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Più rilevante
lyra_belrosee
Stati Uniti
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,...
Utile?
jaxon_wilde0
Stati Uniti
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! 👍
Utile?
felixvane
Stati Uniti
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.
Utile?
keal_doyle
Regno Unito
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.
Utile?
rushingstan
Stati Uniti
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...
Utile?
