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- FDA Submissions: 510(K), IDE, PMA, Product Reports.
- FDA Registrations and Listings
- Agent for Non-USA firms Effective February 11, 2002 , Foreign firms must register with FDA and designate a US Agent. The responsibilities of the United States agent include: assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States , and assisting FDA in scheduling inspections of the foreign establishment. Link to more information on US Agents
- ISO-13485 and CE Marking Preparation
- Risk and Hazard Analysis
- FDA Quality System audit assistance
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