In this episode of the MedTech Innovation 360, we delve into risk assessment and management within medical device development. Exploring the definitions of risk, we differentiate between risk assessment and risk management, stressing the importance of early identification and mitigation. Key points include the relationship between risk and hazards, the role of Failure Modes Effects Analysis (FMEA) in identifying potential failures, the significance of ISO 14971 as a guiding standard, and the ...
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In this episode of the MedTech Innovation 360, we delve into risk assessment and management within medical device development. Exploring the definitions of risk, we differentiate between risk assessment and risk management, stressing the importance of early identification and mitigation. Key points include the relationship between risk and hazards, the role of Failure Modes Effects Analysis (FMEA) in identifying potential failures, the significance of ISO 14971 as a guiding standard, and the ...
#2 Best Practices for Conducting User Research in Medical Device Development
MedTech Innovation 360
45 minutes
2 years ago
#2 Best Practices for Conducting User Research in Medical Device Development
In this episode, we will be discussing the best practices for conducting user research in medical device development. User research is an imperative step in the product development process, and it helps to ensure that medical devices are safe, effective, and meet the needs of the people who use them. Our speakers will discuss various aspects of user research, including how to recruit and screen participants, how to conduct interviews or surveys, and how to use different research method...
MedTech Innovation 360
In this episode of the MedTech Innovation 360, we delve into risk assessment and management within medical device development. Exploring the definitions of risk, we differentiate between risk assessment and risk management, stressing the importance of early identification and mitigation. Key points include the relationship between risk and hazards, the role of Failure Modes Effects Analysis (FMEA) in identifying potential failures, the significance of ISO 14971 as a guiding standard, and the ...
