Welcome to our Ask The Expert series, where the Criterion Edge team of experts take your questions on trending industry topics relevant to the work you do every day. From […]
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 […]
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 […]
Overview In the fast-paced environment of pharmaceutical development, project demands often outstrip available resources, leading to critical bottlenecks in deliverables. Teams frequently find themselves finishing one clinical study and needing […]
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 […]
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 […]
A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar, we’ll explore how a good SLR […]
A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar, we’ll explore how a well-designed systematic […]
Artificial intelligence and large language models (LLMs) are transforming how medical device companies approach regulatory writing, but questions remain around how to implement these tools effectively and responsibly, and whether […]
In the pharmaceutical industry, systematic literature reviews (SLRs) can be a valuable tool — not just for regulatory submissions, but as a strategic foundation for drug development, clinical trial design, […]
As scientific literature continues to grow, traditional systematic literature reviews (SLRs) can leave valuable insights siloed in individual reports. AI-powered evidence intelligence can help life sciences teams make scientific evidence […]
AI is becoming increasingly common in scientific and regulatory writing, but using it effectively requires more than simply automating existing workflows. In regulated environments, teams must balance AI-driven efficiency with […]
