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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
desconectado •
Tiempo medio de respuesta: 1 hora
Revisa mis servicios

Reglamentos para dispositivos médicos
I will iso 13485 consulting and certification preparation for medical devices

Certificación de TI y ciberseguridad
I will achieve iso 9001 certification with efficient qms
Porfolio
159 Reseñas
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1-5 de 159 reseñas
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awenckebach
Cliente recurrente

Suiza
Fast and efficeint, in summary very good work. We are now engage Myryam on a more sustained work, and looking forward to the next phases of work.
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awenckebach
Cliente recurrente

Suiza
Maryam reacted quite fast to address our gaps in the ISO 13485 process. Efficient
Respuesta del Freelancer
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andremoreira04

Portugal
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mary_gonzales1

Estados Unidos
Very satisfied with the service. The seller delivered a polished result and maintained a professional workflow throughout.
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willardadk

Estados Unidos
The seller showed strong attention to detail and a clear understanding of the project objectives.
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