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- Implemented integrated ISO 13485 and FDA quality system (QSR)for
Electro medical devices
- Compiled and prepared new product documentation to support
Australian and international assigned projects
- Regulatory submissions (510(k) notifications, CE Mark, Canadian,
TGA Class III and Conformity Assessment
- Prepared Design Dossiers and Technical Files for medical devices
- Characterized design control regulatory requirements for Australian
and international markets
- Validation and verification of Medical device software
Let Acrapack assist you with your quality
system development or regulatory activities
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