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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.jpg
Erin Keith - FDA.jpg

Susan Neadle

Erin Keith
OPEQ/CDRH, US FDA

Nastassia Tamari
Cybersecurity, US FDA

Presenters

Instructors

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