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Sara H
@sariahammad
Biomedical Engineer, Medical Device Regulatory Consultant, EU MDR and FDA
Pakistan
Englisch, Urdu
Über mich
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
offline •
Meine Dienstleistungen
Regulierung für Medizinprodukte
I will classify your medical device for eu mdr and fda regulations
Regulierung für Medizinprodukte
I will guide you on ce marking and eu mdr compliance for medical devices
