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- Preparation and Review of regulatory submissions, Applications for TGA and FDA registrations and for CE marking
- Processes and Systems reviews
- Technical Reviews
- Technical dossier reviews
- Mock audits
- Implement ISO 13485 quality system compliant with FDA Quality System
Requirements
- Labelling and Promotional Materials reviews
- Regulatory advice and consulting support for post market requirements
- Training in Medical device regulations, FDA Quality System Requirements, ISO 13485, GMP
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