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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
États-Unis
Anglais
À propos de moi
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.
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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1 à 5 avis sur 159
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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?

