Medical Device Risk Management Tools: FMEA Does Not Equal Risk Assessment – Webinar Recording/Transcript
Risk assessment is key in the medical device development process and involves more than simply conducting failure modes and effects analysis (FMEA). To learn how to better assess, reduce and manage the risks that accompany medical device development, don’t miss this webinar, led by Eliot Zaiken, an expert with more than 30 years’ experience in the medical device arena.
Zaiken explains the ISO 14971 risk management process, including how to identify and mitigate hazardous situations, as well as discuss recommended methodologies to identify, reduce and eliminate failure modes.
You’ll also learn about the FDA’s specific expectations for risk management and required deliverables in accordance with the upcoming merger of the Quality System Regulation and ISO 13485. You will come away with a clear understanding of the difference between a risk assessment and an FMEA as well as the synergistic link between the two.
- Where risk management is used in the medical device development process
- The different types of FMEAs and how they are used
- Risk control and mitigation methodologies to deploy during the development process
If you want to gain a clear understanding of the risk management process for medical device development — don’t miss this chance to gain key insights from a top expert in the field..
Meet Your Presenter
Eliot Zaiken 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 roles included 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
- Quality and regulatory professionals
- Design, manufacture, and process engineers
- Clinical and medical affairs representatives
- Project and program managers
- Supply chain engineers
- Medical device QMS auditors
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Aug. 24, 2023