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- Implemented of ISO 13485 quality system compliant with FDA Quality System
requirements for Electro medical devices
- Validation and verification of Medical device software
- Compile and prepare new product documentation to support
domestic/international assigned projects including:
- Regulatory submissions (510(k) notifications, CE Mark, Canadian,
TGA Class III and Conformity Assessment
- Preparation of Design Dossiers and Technical Files
- Define design control regulatory requirements for domestic and
international markets
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