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...
Dive into the intricacies of auditing within the medical device industry with the latest MEDIcept White Paper! In this insightful piece written by Quality Systems Consultant, Jeff Groskopf, he explores the pivotal role audit management plays in fostering a culture of...
Join us for Part 1 of our Risk Management Series where we tackle the challenge of prioritizing risk management activities in medical device development. In this White Paper, we delve into the common pitfalls faced by both large companies and startups, providing...
Are you seeking to improve your understanding of medical device audits? Does auditing burden your company or are you failing to receive the improvement benefits? MEDIcept and this White Paper are here to help. Auditing 101 is an ongoing series of papers that will...