Live Webinar: Incorporating Human Factors into the Risk Management Process When: Friday August 27, 2021 - 01:00 PM Duration: 90 Minutes.
This webinar will discuss how to integrate Human Factors Engineering into the Risk Management process as per the requirements of the FDA’s Guidance for Applying Human Factors and Usability Engineering to Medical Devices (2_2016) and IEC62366-1 Application of usability engineering to medical devices (2_2015) and ISO 14971 Medical devices - Application of risk management to medical devices (12_2019). Both Human Factors Engineering and Risk Management standards are complementary in their goals to reduce the safety risks associated with medical devices to levels as low as reasonably possible. This webinar presents organizations with opportunities and insights on how to align and streamline their approach.
Areas Covered in the Webinar:
What is Medical Device Risk
When should it be Considered
Medical Device Risk Considerations
Benefits of Risk Management
Risk Management – Outside of Medical Devices
Human Factors and Risk Management
Collection & Analysis of Risk Based Safety Data
Maintaining Risk Management throughout the product development lifecycle