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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Stati Uniti
Inglese
Chi sono
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.
Competenze
Maryam
offline •
Tempo di risposta medio: 1 ora
Consulta i miei servizi
Regolamentazione per dispositivi medici
I will iso 13485 consulting and certification preparation for medical devices
Certificazione IT e Cybersecurity
I will achieve iso 9001 certification with efficient qms
Portfolio
159 Recensioni
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Valutazione dettagliata
- Livello di comunicazione del venditore
- Qualità della consegna
- Valore della consegna
1-5 di 159 recensioni
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Più rilevante
awenckebach
Cliente abituale
Svizzera
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
Cliente abituale
Svizzera
Maryam reacted quite fast to address our gaps in the ISO 13485 process. Efficient
Risposta del venditore
Utile?
andremoreira04
Portogallo
Utile?
mary_gonzales1
Stati Uniti
Very satisfied with the service. The seller delivered a polished result and maintained a professional workflow throughout.
Utile?
willardadk
Stati Uniti
The seller showed strong attention to detail and a clear understanding of the project objectives.
Utile?
