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Anticipated Agenda

Welcome by local dignitary

Keynote Speech by the US FDA  |  EU Notified Body

Technical Presentations

Lunches and refreshment breaks are included

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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