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 ...
#7 FDA Regulations Guide for Medical Device Developers
MedTech Innovation 360
41 minutes
1 year ago
#7 FDA Regulations Guide for Medical Device Developers
In this episode, "FDA Regulations Guide for Medical Device Developers," listeners are taken on a comprehensive journey into the intricate world of FDA regulations governing medical device development. Through insightful discussions with industry experts, including Elaine Duncan from Paladin Medical, the podcast explores key concepts such as defining medical devices, understanding indications for use, and classifying devices according to FDA guidelines. The episode delves into the importance o...
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 ...
