FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance Documents for MedTech

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:
Presentations from MCRA’s experts on the new FDA guidance
Roundtable discussion with MCRA experts and Innolitics executives
Live Q&A Session
Speakers:
Nikki Batista: MCRA - Vice President, Digital Health and Regulatory Affairs
Alex Cadotte, Ph.D.: MCRA - Senior Director, Digital Health and Imaging Regulatory Affairs
Lauren White, MBA, CISSP: MCRA - Director of IT and Security
Dan Goldstein: MCRA - Senior Director, Quality Assurance
J. David Giese: Innolitics - CEO and Co-Founder
Yujan Shresha, MD: Innolitics - CTO and Co-Founder
About MCRA:
MCRA is the leading therapy focused CRO and advisory firm, and the pioneer in integrating six core service offerings to support the medical device industry: Regulatory Affairs, Clinical Research, Reimbursement and Market Access, Quality Assurance, Healthcare Compliance and Cybersecurity. Our global footprint with leadership across the top three medical device markets, US, Europe and Japan, integrated services expertise, and deep therapeutic knowledge makes us the leading partner to bring medical innovation to market around the world.
Learn more about MCRA on our website: www.mcra.com.