In recent months, the US FDA has published several guidance documents related to SaMD, SiMD and connected medical devices that shift the regulatory landscape for both new and experienced medical device companies. This 90-minute webinar provides an overview of these landscape shifts and a panel discussion on the practical implications and applications with experienced regulatory, quality, cybersecurity and software development professionals who navigate this every day. Hear the lessons learned from our collective experience from working with hundreds of companies.
This webinar discusses Software and Cybersecurity Documentation, Quality Management Systems, and how to be FDA Compliant with this new guidance.
The webinar features:
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Presentations from MCRA’s experts on the new FDA guidance
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Roundtable discussion with MCRA experts and Innolitics executives
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Live Q&A
Session Speakers:
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Nikki Batista: MCRA - Vice President, Digital Health and Regulatory Affairs
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Alex Cadotte, Ph.D.: MCRA - Senior Director, Digital Health and Imaging Regulatory Affairs
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Lauren White, MBA, CISSP: MCRA - Director of IT and Security
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Dan Goldstein: MCRA - Senior Director, Quality Assurance
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J. David Giese: Innolitics - CEO and Co-Founder
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Yujan Shresha, MD: Innolitics - CTO and Co-Founder
This webinar took place on September 26, 2023. Webinar hosted by MCRA.