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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Estados Unidos
Inglés
Sobre mí
I am a dedicated medical devices expert with extensive experience in all aspects of laws, standards, regulations, directives, and guidelines related to the medical devices industry. I specialize in navigating global regulatory frameworks, I specialize in navigating complex regulatory landscapes, including ISO, CE MARK, MDR, FDA, EMA, TGA, and ECREP, SFDA, etc. With expertise of decades I help clients achieve regulatory compliance and market access for their medical devices. My services include regulatory strategy, technical documentation, regulatory submissions, and post-market surveillance.
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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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
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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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