Where do you start? How do you know your device qualifies? Join our panel with RQM+ FDA experts.
RQM+ Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer audience questions. Every episode is added to our podcast, too.
The U.S. FDA provides multiple pathways to expedite regulatory clearance/approval for much needed innovative devices. As a regulatory consultancy, we've had the opportunity to support manufacturers achieve successful entry to the market using these various pathways. We're very excited about FDA's recently released Safer Technologies Program (STeP) Guidance Document which fills in the gaps for devices that target important conditions that are not covered by the Breakthrough Devices Program and provides another mechanism to get safer treatments more quickly to the patients who need them.
We often get the questions, "Where do I start?" and "How do I know if my device qualifies?" In this Live! show, our panel of regulatory experts (including former FDA CDRH representatives) will discuss the following and more:
If you'd like to learn more about the options and challenges associated with getting innovative devices to the US market, please join us and bring your tough questions for our panel to answer live!
The panel will include:
Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
Kevin Go - Project Engineer (former FDA CDRH Lead Reviewer)
Bryan Pinder - Project Engineer (former FDA CDRH Lead Reviewer)