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 […]
While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER). […]
Join Criterion Edge on June 5th, 2024, at 12 PM CST for an enlightening session with Geoff Fatzinger, our Senior Regulatory Consultant. Dive deep into the essentials of FDA interactions in our webinar: "Understanding FDA: Essentials for Briefing Books in Pre-IND, Pre-NDA, and Pre-BLA Meetings." Uncover the intricacies of FDA expectations and learn how to […]
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 […]
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, […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
