top of page
PUBLICATIONS & POSTS
Access in-depth white papers covering medical device quality systems, risk management methodologies, and regulatory strategy. Each publication reflects our commitment to rigorous analysis and practical implementation.
White Papers
Reducing Time To Market and Promoting Innovation while Ensuring Device Safety
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
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
FDA Public Workshop “FY 2019 Generic Drug Regulatory Science Initiatives Wednesday, May 1, 2019”
Cybersecurity Risk Management for Device Manufacturers
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.
Best Practices in Applying Risk Management Terminology
Confused with risk management terms (e.g. harms, hazards, hazardous situations, causes)? Read this article and find out best practices how to distinguish them.
Documenting Medical Device Risk Management through the Risk Traceability Summary
Is FMEA alone adequate for risk analysis? How to document a comprehensive risk analysis? Read this article to get some insights from the experts.
Medical Device Risk Management and Safety Cases
Find out FDA's thinking about risk management and safety cases.
Reducing Risks and Recalls: Safety Assurance Cases for Medical Devices
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.
bottom of page