Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024

Webinar , United States

The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR. Dr. Sarah […]

Trending Topics: From the AI Act to Orphan Devices, Key Takeaways from RAPS EU Convergence 2024

Webinar , United States

Welcome to our new Trending Topics webinar series! Each webinar in this series will present key trending topics, late-breaking regulatory news and other hot-button topics from medical and in vitro device industry leaders. Tap into the critical conversations that are shaping the future of the MedTech industry and join us as we explore current issues, […]

Pharma in Focus: The Role of Real-World Evidence (RWE) in Regulatory Submissions

Webinar , United States

In this webinar, we will explore the strategic use of Real-World Evidence (RWE) throughout product development. Participants will learn about the integration of RWE from various sources and how it can be used to bolster regulatory submissions. Learning Objectives: Understand the sources of Real-World Data (RWD) which are used to generate RWE Explore the main […]

Emerging Trends in Global Regulations: Insights Into More Efficient Regulatory Writing Practices

Webinar , United States

Join us for an insightful and interactive webinar where we explore the ever-evolving landscape of global regulatory trends and their impact on information across all industries. As regulations governing product development, agency interactions, and filing for product approvals become increasingly complex and geographically diverse, regulatory professionals and medical writers must adapt to ensure the compliance, […]

Ask the Expert: The Role of Real-World Evidence (RWE) in Regulatory Submissions

Webinar , United States

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 global regulatory challenges, clinical evidence issues or regulatory writing best practices, the goal of this Q&A format is to share information, ideas and solutions. Today’s […]

Good Science vs. Bad Writing: Strategies for Building an Effective Scientific Writing Team

Webinar , United States

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 […]

Devices in Focus: How to Save Time & Money with Real World Evidence (RWE)

Webinar , United States

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 […]

Overcoming Deadline Bottlenecks in Pharma: How a Writing Team Can Help

Webinar , United States

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 to pivot to the next project development, leaving tasks like CSR completion sidelined. Additionally, competing priorities, from regulatory requirements to study design revisions, can push […]

FDA Pre-Determined Change Control Plan (PCCP): Recommendations for Planning Your Strategy and Approach

Webinar , United States

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 […]

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

Webinar , United States

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 […]

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

Webinar , United States

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 […]

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

Webinar , United States

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 literature review 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 […]

Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Read more about our privacy policy here.