Products
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How to Create a Risk Mitigation Table Webinar
CourseThis webinar teaches you how to create a Risk Mitigation Table systematically for your FDA De Novo submission.
$79
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Hosting FDA Inspections (including WI-009)
CourseLearn how to host an FDA inspector and receive work instructions when you purchase our FDA inspection webinar training bundle.
$299
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513g Submission Webinar
CourseThis 513g submission webinar will give you step-by-step instructions for completing the FDA PreSTAR template.
$149
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SteP vs Breakthrough Device Designation Webinar
CourseThis webinar will explain the advantages associated with receiving approval for the STeP application or receiving Breakthrough Device Designation. You will also learn what the required contents and format are for both submissions.
$149
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WI-003: Electronic Submission Gateway Work Instruction
CourseThis work instruction provides detailed instructions for creating an electronic submission gateway (ESG) for the submission of a Medical Device Report (MDR), 510(k), and other types of electronic submissions to the US FDA or Health Canada.
$199
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Design and Development Process Bundle
BundleThis Design and Development Bundle contains five of our SOPs at a 20% discount.
$1,436