Join us at the ECCMID in Lisbon, Portugal Criterion Edge provides medical and regulatory writing services for the in vitro diagnostics (IVD) industry and will be attending the 32nd European Congress of Clinical Microbiology & Infectious Diseases in Lisbon, Portugal, from April 23-26, 2022. President, Laurie Mitchell, will be on site at the convention ready […]
This session's topic: Tips For How to Avoid Common Notified Body Review Findings Criterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions based upon Notified Body review and feedback. Addressing NB feedback costs your team time and effort and may threaten critical submission deadlines. However many of […]
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 attending RAPS Euro Convergence in Amsterdam, from May 10-12. Our specialists will be on site at the conference ready to meet you and your team […]
Ask 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 […]
Scoping 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? […]
The 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 […]
Join 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 […]
Ask 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, […]
Bridging 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. […]
Demonstration 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, […]
Clinical 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 […]
Ask 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, […]
