Products
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Benefit-Risk Analysis Webinar
CourseThis webinar explains how to conduct a risk-benefit analysis in accordance with ISO 14971:2019, Clause 7.4. The webinar references our Risk Managment Procedure (SYS-010), which is not included, but the benefit-risk analysis template (TMP-034) is.
$79
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FDA Special Controls Webinar
CourseIn this training, we learn how to find special controls guidance documents and where to find special controls for newer regulations that do not have a stand-alone guidance document.
$49
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Identifying a Potential Predicate Webinar
CourseThis webinar will teach you how to identify a potential predicate. We’ve done this before, but now we have a template that walks you step-by-step through exactly what we do.
$79
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Classification Rationale Webinar
CourseIn our classification rationale webinar, you will learn how to write a classification rationale for De Novo applications.
$49
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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