publications
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 argument, and how the regulators perform effective safety review.
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 emphasizes the importance of effective risk management in advancing regulatory science.
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”
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 manufacturer who has been practicing safety risk management ? Read this article and find out ways to fully leverage your safety risk management practices for cybersecurity risk management.
This article was originally published in the January/February 2016 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 AAMI-copyrighted material requires written permission from AAMI.
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 and find out best practices how to distinguish them.
This article was originally published in the spring 2015 issue of AAMI Horizons (special edition on risk management), a semiannually, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation, www.aami.org. Posted with permission. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.
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? Read this article to get some insights from the experts.
This article was originally published in the spring 2015 issue of AAMI Horizons (special edition on risk management), a semiannually, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation, www.aami.org. Posted with permission. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.
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 the spring 2015 issue of AAMI Horizons. Please contact AAMI for a copy.
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 AAMI-copyrighted material requires written permission from AAMI.