Medical Device Risk Management Tools — FMEA Does Not Equal Risk Assessment
Risk assessment is an essential tool of medical device risk management — it’s no longer enough to conduct a failure mode and effects analysis (FMEA) and call it “complete.”
Learn how to properly assess, reduce and manage risks associated with your medical devices and comply with ISO 14971 with the Medical Device Risk Management Tools — FMEA Does Not Equal Risk Assessment management report.
The report compares risk assessment’s top-down approach to predicting harm with FMEA’s bottom-up approach to targeting the point of failure and reducing the chances for recurrence. It also explains how to use both approaches in tandem.
- Understand key deliverables of ISO 14971 risk management methodology
- Learn the FDA’s specific expectations for risk management
- Understand the differences and similarities between risk assessment and FMEA
- Distinguish between the different types of FMEA and how they are used
- Learn how risk assessment and FMEA work in tandem
- Master risk control/mitigation methodologies
Ensure that your medical device will be safe, effective and fully compliant with ISO 14971 by purchasing this report today.
About the Contributor
Eliot Zaiken, President, Technology Device Enterprises, is a quality expert with more than 30 years’ experience working in the medical device arena as a project leader for the development of devices and as a quality/regulatory engineer for Class I, II and III devices. His career has included roles overseeing and auditing quality management systems, design controls, risk management, complaint systems, supplier management, process validation and postmarket surveillance. He is a Certified Quality Engineer (CQE), a Certified Quality Auditor (CQA), a Certified Biomedical Device Auditor (CBDA) and an ISO 13485 Certified Auditor.
Who Will Benefit
- Design engineers
- Process engineers
- Manufacturing engineers
- Quality and regulatory professionals
- Medical affairs/clinical affairs representatives
- Project/program managers
- Medical device QMS auditors
- Supply chain engineers
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