Events

Writing is not an innate talent, but a learned skill requiring extensive training and practice. Scientific writing is no exception.  As scientists, we have all seen examples of how bad writing and ineffective communication can detract from good science. The goal of this presentation is to describe strategies to support effective partnerships between regulatory experts […]

Real world evidence is increasingly important for companies seeking to demonstrate device performance without the time and expense of extensive clinical trials. This webinar will explore how to effectively use real-world evidence in regulatory submissions to accelerate product approvals and meet post-market surveillance requirements. Learning Objectives: Summarize recent regulatory guidance pertaining to the use of […]

Overview Understand the intricacies of the FDA’s Pre-Determined Change Control Plan (PCCP) and its application across medical devices and in vitro diagnostics (IVDs). This webinar is designed for global regulatory and quality professionals aiming to streamline their strategies for managing post-market device modifications. Attendees will walk away with a deeper understanding of regulatory changes and […]

Here we are, nearly eight years after the publication of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745 (MDR). As the May 2025 deadlines loom, many manufacturers are facing the reality of what implementing these regulations actually entails. While the manufacturers seem to have been given more […]