Title |
FDA Approval of Medical and Diagnostic Devices: New World Regulatory Solutions |
Description |
NWRS' expertise encompasses FDA pre-market notifications including protocol development, Investigational Device Exemptions (IDE), 510(k) submissions and premarket applications (PMA), CLIA waiver petitions, quality system management for cGMP compliance, CE marking and ISO certification, risk management, labeling and advertising, complaint handling, post marketing surveillance, recalls, vigilance and adverse event reporting, product and establishment registrations and laboratory studies. |
Keywords |
protocol development, Investigational Device Exemptions, IDE, 510(k), premarket applications, PMA), CLIA waiver, quality system management, cGMP compliance, CE marking, ISO certification, risk management, labeling, complaint handling, post marketing surveillance, recalls, vigilance, adverse event reporting, product and establishment registrations, laboratory studies |
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