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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
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.
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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- Kwaliteit van de levering
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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?
