MedTech Safety
Anticipated Agenda
Welcome by local dignitary
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Keynote Speech by the US FDA | EU Notified Body
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Technical Presentations
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Lunches and refreshment breaks are included
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(Detailed Program will be published later)
Major Topics
- AI/ML and risk management
- Cybersecurity and medical device safety
- Innovations in risk management
- Regulatory trends with impact on risk management
- Use of SW tools and automation in risk management
- Clinical perspectives for risk management
- The business case for good risk management
- Usability engineering and medical device safety
- Engineering safety into medical devices
- Best practices in post-market risk management
- Risk management process maturity assessment & benchmarking
- The future of ISO 14971
Additional Benefits
- Expert panel discussions
- Roundtable discussions for sharing and collaborations
- Networking opportunities
- Tutorials and workshops
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Keynote Speakers
Susan Neadle
Erin Keith
OPEQ/CDRH, US FDA
Nastassia Tamari
Cybersecurity, US FDA
Presenters
Instructors