RAPS Euro Convergence
Join us at RAPS Euro Convergence in Amsterdam, Netherlands Criterion Edge provides medical and regulatory writing services for the medical device, pharmaceutical, and in vitro diagnostics industries and will be […]
12 events found.
Events
- Park Inn by Radisson Amsterdam City West , Netherlands
Ask the Writers
Virtual Q&AAsk the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, will outline the must-have elements for two very similar regulatory […]
Free
Scoping Your MDR & IVDR Writing Projects
Webinar , United StatesScoping Your MDR and IVDR Writing Projects - The Forgotten Step In most of our webinars, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However, we’ve never discussed what happens before the writing process begins. So what do you need before you get started? […]
FreeThe Role of RA in the Clinical and Performance Evaluation Process
Webinar , United StatesThe Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success Regulatory Affairs plays a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. From the early planning stage […]
Free
Medtech Summit
Clayton Hotel Burlington Road Leeson Street Upper, Dublin, IrelandJoin us at Medtech Summit in Dublin, Ireland Criterion Edge provides medical and regulatory writing services for the medical device industry and will be attending Medtech Summit in Dublin, Ireland, from June 20-24. Our specialists will be on site at the convention ready to meet you and your team to discuss your writing or project […]
ATE: The Role of RA in the Clinical and Performance Evaluation Process
Virtual Q&AAsk the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical and performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. In this session, […]
FreeBridging the Gaps: Clinical Data for GSPRs
Webinar , United StatesBridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists and the device meets specific criteria. […]
FreeDemonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process
Webinar , United StatesDemonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process In the first part of our webinar series, we discussed Legacy Devices, WET devices, and devices exempt from Clinical Investigations under Article 61, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar, […]
FreeCER Critical Concepts
Webinar , United StatesClinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER - Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze […]
FreeAsk the Expert: Clinical Evaluation Report Critical Concepts
Virtual Q&AAsk the Expert: Clinical Evaluation Report Template and Critical Concepts This session is presented from the point of view of seasoned MDR-compliant CER medical writers. In this 45-minute live Q&A, we will answer questions regarding critical concepts for a clinical evaluation report template such as safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, […]
FreeCritical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency
Webinar , United StatesCritical 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 […]
FreeCritical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
Webinar , United StatesCritical 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
