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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Vereinigte Staaten
Englisch
Über mich
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.
Kompetenzen
Maryam
offline •
Durchschnittliche Antwortzeit: 1 Stunde
Meine Dienstleistungen
Regulierung für Medizinprodukte
I will iso 13485 consulting and certification preparation for medical devices
IT- und Cybersicherheit-Zertifizierung
I will achieve iso 9001 certification with efficient qms
Portfolio
159 Bewertungen
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awenckebach
Wiederkehrender Kunde
Schweiz
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.
Hilfreich?
awenckebach
Wiederkehrender Kunde
Schweiz
Maryam reacted quite fast to address our gaps in the ISO 13485 process. Efficient
Antwort des Freelancers
Hilfreich?
andremoreira04
Portugal
Hilfreich?
mary_gonzales1
Vereinigte Staaten
Very satisfied with the service. The seller delivered a polished result and maintained a professional workflow throughout.
Hilfreich?
willardadk
Vereinigte Staaten
The seller showed strong attention to detail and a clear understanding of the project objectives.
Hilfreich?
