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I will fda medical device labeling and packaging compliance
Medical Device Regulatory Affairs : FDA Labeling and Technical Documentation
Pharmaceutical and medical device professional with experience in Regulatory Affairs, CMC, Quality and GMP. Familiar with drug products, APIs, excipients, formulations, manufacturing processes, CTAs a...
Over deze dienst
Are you planning to market a medical device in the US, European Union, Switzerland, Australia or another international market?
I provide regulatory review and research support for medical device labeling, packaging and UDI requirements based on your device and target market.
Services may include:
Medical device label and packaging review
Country specific labeling requirements
UDI requirements and implementation support
US FDA labeling and GUDID requirements
EU MDR labeling and UDI requirements
Switzerland medical device labeling requirements
Australia medical device labeling research
Symbols, manufacturer and representative information
IFU and packaging requirements
Regulatory change and requirement research
Multi market labeling comparison
Identification of labeling updates needed for a target market
My background includes hands on experience with medical device quality and regulatory activities, including labeling, UDI, GUDID, EUDAMED, international regulatory requirements and regulatory change support.
Please contact me before ordering with your device type, classification and target market so I can confirm the appropriate scope.
Type document:
Technische specificaties
•
Regelgevingsdocumenten
Taal:
Engels
•
Frans
Voorkeur voor een leveringsstijl
Laat het de freelancer weten als je voorkeuren voor of zorgen hebt over het gebruik van AI-tools voor het voltooien en/of leveren van je bestelling.
