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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
Stati Uniti
Inglese
Chi sono
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.
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?
