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Sara H
@sariahammad
Biomedical Engineer, Medical Device Regulatory Consultant, EU MDR and FDA
Pakistan
Anglais, Ourdou
À propos de moi
Biomedical Engineer (BEng, City University of London) providing regulatory guidance for medical devices targeting EU and US markets. I support startups and manufacturers with EU MDR and FDA device classification, regulatory pathway guidance, CE Technical File documentation structure, ISO 14971 risk management framework, and labeling/IFU compliance review. My goal is to simplify regulatory requirements and help clients understand the steps needed for CE marking and FDA clearance.
Please contact me before ordering so we can discuss your device and regulatory needs.
Sara H
hors ligne •
Voir mes services
Réglementation des dispositifs médicaux
I will classify your medical device for eu mdr and fda regulations
Réglementation des dispositifs médicaux
I will guide you on ce marking and eu mdr compliance for medical devices
