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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
États-Unis
Anglais
À propos de moi
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.
Compétences
Maryam
hors ligne •
Temps de réponse moyen de 1 heure
Voir mes services
Réglementation des dispositifs médicaux
I will iso 13485 consulting and certification preparation for medical devices
Certification en informatique et cybersécurité
I will achieve iso 9001 certification with efficient qms
Portfolio
159 Avis
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Les plus pertinents
awenckebach
Client récurrent
Suisse
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.
Utile?
awenckebach
Client récurrent
Suisse
Maryam reacted quite fast to address our gaps in the ISO 13485 process. Efficient
Réponse du freelance
Utile?
andremoreira04
Portugal
Utile?
mary_gonzales1
États-Unis
Very satisfied with the service. The seller delivered a polished result and maintained a professional workflow throughout.
Utile?
willardadk
États-Unis
The seller showed strong attention to detail and a clear understanding of the project objectives.
Utile?
