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Maryam
@maryleaf
Level 2
Certified Regulatory Affairs Professional for Medical Industry
United States
English
About me
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 •
Average response time: 1 hour
See my services
Medical Device Regulatory
I will iso 13485 consulting and certification preparation for medical devices
IT & Cybersecurity Certification
I will achieve iso 9001 certification with efficient qms
Portfolio
159 Reviews
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Rating Breakdown
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- Value of delivery
1-5 out of 159 Reviews
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awenckebach
Repeat Client
Switzerland
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.
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awenckebach
Repeat Client
Switzerland
Maryam reacted quite fast to address our gaps in the ISO 13485 process. Efficient
Seller's Response
Helpful?
andremoreira04
Portugal
Helpful?
mary_gonzales1
United States
Very satisfied with the service. The seller delivered a polished result and maintained a professional workflow throughout.
Helpful?
willardadk
United States
The seller showed strong attention to detail and a clear understanding of the project objectives.
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