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This webinar discusses software and cybersecurity documentation, quality management systems, and how to be FDA compliant with these new guidelines.
The webinar includes:
Presentations from MCRA's experts on the new FDA guidelines
Roundtable discussion with MCRA experts and Innolitics executives
Live question and answer 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 services 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 in the top three medical device markets, US, Europe and Japan, integrated services expertise and deep therapeutic knowledge makes us the leading partner to commercialize medical innovation around the world .
Read more about MCRA on our website: www.mcra.com.
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