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White Papers
Reducing Risks and Recalls: Safety Assurance Cases for Medical Devices
by Sherman Eagles and Fubin Wu Ever wondering how to improve your risk management methods and practices? Read this article to get some insights on how safety assurance cases can help. This article was originally published in the January/February 2014 issue of BI&T (Biomedical Instrumentation & Technology, a bimonthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation, www.aami.org . Posted with permission. Any other distribution of AA
Medical Device Risk Management and Safety Cases
by Paul L. Jones and Al Taylor from FDA Find out FDA's thinking about risk management and safety cases. This article was published in...
Documenting Medical Device Risk Management through the Risk Traceability Summary
by Edwin Bills, Stan Mastrangelo, and Fubin Wu Is FMEA alone adequate for risk analysis? How to document a comprehensive risk analysis?...
Best Practices in Applying Risk Management Terminology
by Fubin Wu and Alan Kusinitz Confused with risk management terms (e.g. harms, hazards, hazardous situations, causes)? Read this article...
Cybersecurity Risk Management for Device Manufacturers
by Fubin Wu and Sherman Eagles Cybersecurity risk management for Medical Devices is now expected by FDA. How to do it as a device...
Introduction of Assurance Case Method and its Application in Regulatory Science
by Fubin Wu FDA PUBLIC WORKSHOP “FY 2019 GENERIC DRUG REGULATORY SCIENCE INITIATIVES WEDNESDAY, MAY 1, 2019”
Advancing Regulatory Science through Comprehensive, Rational Risk Management
by Fubin Wu, Edwin L. Bills and Jessica Eisner The article highlights key principals (and pitfalls) for effective risk management and...
Reducing Time To Market and Promoting Innovation while Ensuring Device Safety
by Fubin Wu and Jessica Eisner The article discusses what safety means, how the device manufacturers develop effective device safety...
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