MDR Webinars

Events Search and Views Navigation

Event Views Navigation

Today

Latest Past Events

Featured

Beyond AI: Why the Future of Scientific and Regulatory Writing Is Human + AI

Webinar

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 scientific judgment, evidence traceability, quality control, and human accountability. In this webinar, Criterion Edge explores a human + AI approach to scientific and regulatory writing, […]

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 […]

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

Webinar

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 […]

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

Webinar

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 […]

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

Webinar

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 […]

It’s All Interconnected: Hidden Traps That Can Derail Your PER

Webinar

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a […]

Ask the Expert: Plain Language Written Content for Multiple Audiences: Effective Communication for Patients, Caregivers, and HCPs

Virtual Q&A

Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written content ensures key health information and clinical research findings are understandable and accessible to all. If you or your team are producing […]

Free

Integration of Plain Language Content and Infographics into HCP Communication Channels: Strategies to Enhance HCP Engagement

Webinar

Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all. But you might wonder “Isn’t […]

Free

Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCP Patient Sections

Webinar

Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all. In this second presentation of […]

Free

Critical Concepts Medical Device Software: Approaches to Determining Risk Classification, Qualification, and Safety and Performance Outcomes

Webinar

In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic, the FDA released 4 guidance documents in 2022 alone, on topics ranging from cyber security, medical image devices, and mobile medical applications. Furthermore, the European MDR- EU 2017/745 and new IVDR – EU 2017/746 regulation contain stipulations […]

Free