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Sunday, Sept. 15
Essential Principles of Medical Device Safety
How can environmental and human factors help to limit device risk?
Tools for Pre-market Risk Evaluation of Devices
Analyzing Medical Device Adverse Events and Applying IMDRF Terms and Codes
Monday, Sept. 16
How do Quality Standards (ISO 14971:2019 and application of risk management) De-Risk Devices?
How Audits and the MDSAP program support QMS
Understanding the Tools for Post-approval Risk Management
In Vitro Diagnostic Devices: Special Risk Considerations
Drug-Device Combination Products: Evaluation and Risk Assessment