Latest Past Events

Leveraging AI in Regulatory Writing — Opportunities, Oversight & What Medical Device Leaders Need to Know

Webinar

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 they actually save time and improve productivity.  In this Ask the Expert session, the team at Criterion Edge will explore how AI and LLMs can […]

Maximizing the Value of Literature Reviews for Medical Device, From Competitive Intelligence to Market Success

Webinar

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 can support regulatory submissions, enhance competitive intelligence, and facilitate post-market surveillance while saving time, money, and resources. Using real-world examples, our experts will share best […]

The Current State of Medical Device Regulations: Strategies to Support a Successful Technical Documentation Assessment (TDA)

Webinar

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 […]

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