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Nederlands
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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Verenigde Staten
Engels
Over mij
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.
Skills
Maryam
offline •
Gemiddelde reactietijd: 1 uur
Bekijk mijn diensten
Regelgeving voor medische hulpmiddelen
I will iso 13485 consulting and certification preparation for medical devices
IT- en cyberbeveiligingscertificering
I will achieve iso 9001 certification with efficient qms
Portfolio
159 Reviews
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Specificering van de beoordeling
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1-5 van 159 reviews
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awenckebach
Terugkerende klant
Zwitserland
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.
Nuttig?
awenckebach
Terugkerende klant
Zwitserland
Maryam reacted quite fast to address our gaps in the ISO 13485 process. Efficient
Reactie van de freelancer
Nuttig?
andremoreira04
Portugal
Nuttig?
mary_gonzales1
Verenigde Staten
Very satisfied with the service. The seller delivered a polished result and maintained a professional workflow throughout.
Nuttig?
willardadk
Verenigde Staten
The seller showed strong attention to detail and a clear understanding of the project objectives.
Nuttig?
