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.
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,...
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...
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...
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...
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...
Unlock the secrets to excellence in clinical research with MEDIcept’s latest white paper, "What Makes a Great Clinical Research Associate? Site and Sponsor Perspectives." Delve into the perspectives of both sites and sponsors to discover the key qualities that define...
Are you seeking to optimize your clinical trial success? Learn about the pivotal role of effective communication between Data Management (DM) teams and Clinical Research Associates (CRAs) in ensuring data integrity and trial adherence to regulatory standards in our...
Get ready for the third installment of our Auditing 101 series: "Prepare, Conduct, Host, & Respond – Navigate for Success." Building on our previous discussions about the principles of medical device auditing and constructing a robust audit management process,...
Understanding the subtle yet impactful differences between hybrid and fully virtual Decentralized Clinical Trials (DCTs) is crucial. Are you ready for your DCT trial? Have you considered all aspects? This MEDIcept White Paper dives deep into the discrepancies we...