Get a copy of the slides from this webinar or click to watch the recording.
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 robust Performance Evaluation Report (PER).
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Get a copy of the slides from this webinar or click to watch the recording.
You have planned a time to complete your Clinical Evaluation Reports to meet the upcoming MDR deadline, but when your team sits down to write, will they have everything they need to complete the job?
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER. This takes more up-front planning than the reports have in the past, and the last thing you want to do is torpedo your writing project timeline by not having everything your team needs when that project begins.
Based on our experiences with clients both large and small, our President, Laurie Mitchell, will share with you some of the biggest issues we have discovered when starting an MDR CER project. And Laurie will also reveal some of the most successful strategies in addressing these issues, up-front and early.
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Get a copy of the slides from this webinar or click to watch the recording.
With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products, however many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR), screening, selection and data extraction.
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
Click here to download a copy of our exclusive white paper, a companion piece to this popular webinar.
Key Takeaways:
• Review the essential steps for conducting a robust, methodologically-sound systematic literature review
• Using a typical case study scenario, learn how to effectively search, identify, screen, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
Sign up for future webinars here.
If you enjoyed this webinar and would like a free consultation, please contact us here.
Get a copy of the slides from this webinar or click to watch the recording.
In this second part of our 2-part webinar series, Criterion Edge will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience authoring MedDev rev. 4 and MDR-compliant CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities. In this series, we will examine the Clinical Data Sources, Equivalence, and Risk/Benefit Analysis Profile sections of the CER.
In the first webinar of this series, we discussed the State of the Art, Safety & Performance Criteria, Equivalence, and Systematic Literature Review.
Click here to get the slides and watch the recording for part 1.
Key Takeaways:
• Understand the key components of a clinical evaluation report (1-min review of last webinar, clinical evidence, SLR, risk benefit, conclusion – have you ensured that your conclusion reflects conclusions from other sections/data?)
• Determine how to evaluate your CER for key requirements of the MDR
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.
Sign up for future webinars here.
If you enjoyed this webinar and would like a free consultation, please contact us here.
Click here to watch the recording.
We had such a large turnout at our previous webinar, How to Assess Your CER for MDR Readiness, Part 1, and left with some questions unanswered. Therefore, President Laurie Mitchell held a live Q&A to respond to questions regarding CER for MDR Readiness. In this webinar, Laurie delves deeper into some of your pressing questions like:
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.
Sign up for future webinars here.
If you enjoyed this webinar and would like a free consultation, please contact us here.
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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