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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Vereinigte Staaten
Englisch
Über mich
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.
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
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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?
