Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency

Webinar , United States

Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency In this webinar, we will review the conformity requirements for “legacy devices” under the MDR and “established devices” under the IVDR to help you harness the potential of effective post market activities. We will discuss how “legacy devices," defined as those previously certified […]

Free

Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies

Webinar , United States

Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to […]

Free

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

Webinar , United States

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

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

Webinar , United States

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

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

Webinar , United States

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

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

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

Webinar , United States

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 […]

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 […]

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 […]

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