White Papers
QMSR Compliance Deadline: February 2, 2026
The FDA’s transition to the new Quality Management System Regulation (QMSR) introduces expanded risk-based expectations, deeper inspection focus, and additional FDA-specific requirements aligned with ISO 13485. Manufacturers should begin preparations now for the February 2026 compliance deadline.
Risk Management Series – Part 5: Assigning Harms and Severity
In part 5 of this ongoing white paper series, authors Gregg Van Citters and Brian Siroka dive into the next step in the risk management process, which is assigning harms and severity. Whether you’re a seasoned professional or new to medical device risk management,...
Risk Management Series – Part 4: Key Terms
Our popular Risk Management White Paper series is back – continuing with a paper centered around all the relevant key terminology. In order to move onto the best practices for conducting a risk assessment, it’s important to clarify and understand some related...
Selecting the Right EDC for your Clinical Trial: The Difference in Device Approval
Dive into the world of clinical trials with our latest White Paper! Discover why selecting the right Electronic Data Capture (EDC) system is crucial for your trial’s success. From enhancing data security to improving user experience, we explore the key factors that...
Risk Management Series – Part 3: Transferring Risks from Fault Trees to FMEAs, URRAs, and SRAs
We are excited to continue our Risk Management Series with Part 3, where we explore how to transfer risks from Fault Tree Analysis (FTA) to Failure Modes and Effects Analysis (FMEA), Use-Related Risk Assessments (URRA), and System Risk Assessments (SRA). In this...
Risk Management Series – Part 2: Using Fault Trees to Focus and Simplify Risk Analysis
Dive into Part 2 of our Risk Management Series, where we explore the transformative potential of Fault Tree Analysis (FTA) for medical devices. Discover how FTA offers a comprehensive, top-down approach to hazard identification, bridging the gap that traditional FMEA...