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 ...
#5 Compliance Matters: Navigating FDA Clearance and ISO Certification for Medical Devices
MedTech Innovation 360
50 minutes
2 years ago
#5 Compliance Matters: Navigating FDA Clearance and ISO Certification for Medical Devices
In the fast-evolving landscape of medical device development, ensuring safety, efficacy, and regulatory compliance is paramount. Join us in this episode as we dive into the intricate world of FDA clearance and ISO certification in the realm of medical devices. From understanding the rigorous regulatory processes to highlighting the importance of meeting these standards, we explore the challenges, benefits, and implications for both manufacturers and end-users. Learn how navigating through the...
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 ...
