Risk Management For Medical Device
- Offered byAmerican Society for Quality (ASQ)
Risk Management For Medical Device at American Society for Quality (ASQ) Overview
Risk Management For Medical Device
at American Society for Quality (ASQ)
Essential Strategies for Mitigating Risks and Ensuring Compliance in the Development and Deployment of Medical Devices
Duration | 7 hours |
Total fee | ₹74,530 |
Mode of learning | Online |
Official Website | Go to Website  |
Credential | Certificate |
Risk Management For Medical Device at American Society for Quality (ASQ) Highlights
Risk Management For Medical Device
at American Society for Quality (ASQ)
- Earn a certification after completion
Risk Management For Medical Device at American Society for Quality (ASQ) Course details
Risk Management For Medical Device
at American Society for Quality (ASQ)
Skills you will learn
Who should do this course?
- Quality managers, engineers, and technicians involved in the development/manufacture of medical devices
What are the course deliverables?
- Identify and analyze hazards of product, process, or service
- Create a process map
- Perform fault tree analyses
- Perform failure mode and effects analyses
- Perform hazard analysis and critical control points
- Understand and analyze software hazards
- Understand basics of human factors and its relationship to risk management
More about this course
- This course illustrates commonly used risk-identification and risk-reducing methods. Through examples the instructor shares practical applications implementing tools described by several of the recently enacted or updated standards and technical reports relevant and applicable to medical device risk management through an ISO/EN 14971: 2019 summary
- The discussion will reveal the minimal changes in Risk Management process from the 2012 to 2019 versions, and will include discussion of the Technical Report TR/ISO 24971:2020, as related to the transfer of several of the 14971 Annexes transferred to the 2020 TR
Risk Management For Medical Device at American Society for Quality (ASQ) Curriculum
Risk Management For Medical Device
at American Society for Quality (ASQ)
Risk management
Fault tree analysis (FTA)
Failure mode and effects analysis (FMEA)
Process mapping
Hazard analysis and critical control point (HACCP)
Human factors
Software safety
Example templates
Summary
Risk Management For Medical Device at American Society for Quality (ASQ) Faculty details
Risk Management For Medical Device
at American Society for Quality (ASQ)
Barrett C. Craner
Barry Craner has nearly 40 years of experience in the management of scientists and engineers in applications in aerospace, Internet technologies, medical devices, and medicine. He has written several design control systems, and has consulted in areas of design control, quality system development, reliability engineering, and risk management. He has audited many medical device companies from 1st, 2nd, and 3rd-party perspectives.
Other courses offered by American Society for Quality (ASQ)
Risk Management For Medical Device
at American Society for Quality (ASQ)
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