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DTSTART;TZID=America/Los_Angeles:20220420T110000
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DTSTAMP:20220520T175031Z
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UID:3375-1650452400-1650456000@criterionedge.com
SUMMARY:How to Establish the Competitive Landscape Within the Scientific Validity Report
DESCRIPTION:In this practical presentation\, Dr. Sarah Chavez\, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally\, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example\, the SLR approach\, data screening\, and data presentation will be addressed. \nYou will learn:\n\nThe importance of the SOA SLR for providing background and general information\nHow to establish acceptance criteria with data\nHow to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process\n\nWho should attend?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. Also\, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend. \nClick here to watch the webinar recording. \nIVDR Essentials: Performance Evaluation Report – Early Planning and Preparation\nHow can scoping help you identify critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER\, so we have developed strategies to keep you and your team on track and help assess your own level of preparedness. Using our CE Scoping checklist\, we will walk through the necessary documents\, SOPs\, processes\, reports\, and templates\, and explain how each of these fits into the overall process of preparing to write. \nThis presentation will emphasize the importance of scoping\, discuss how to develop a checklist\, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process. \nWatch the free webinar recording now.
URL:https://criterionedge.com/event/how-to-establish-the-competitive-landscape-within-the-scientific-validity-report-2/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/establish-the-competitive-landscape-cover-slide-042022.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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DTSTART;TZID=America/Los_Angeles:20220428T110000
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DTSTAMP:20220520T174942Z
CREATED:20220324T235600Z
LAST-MODIFIED:20220520T174942Z
UID:3442-1651143600-1651146300@criterionedge.com
SUMMARY:[Ask the Expert] Common Notified Body Review Findings
DESCRIPTION:This session’s topic: Tips For How to Avoid Common Notified Body Review Findings\nCriterion 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 these issues might have been avoidable with thorough pre-planning\, proper project scoping and asking the right questions from the beginning.  In this “Ask the Expert” question-and-answer session\, we will show you some of the most common issues our writing team encounters with clients who face these revisions and discuss how they can be avoided. Presented from the perspective of experienced medical writers\, we hope to provide examples of how solid planning during your own writing process can help you avoid the most common missteps in your own CER or PER. \nDuring this 45-minute session\, come prepared with your questions for our experts to answer regarding your notified body review findings. Please submit them ahead of time while registering so we have ample time to answer them thoughtfully. Also\, please be aware that answers will be limited to 3 minutes per question. \nThis forum will answer questions on a first come first serve basis\, so please submit all your questions when you register for this event. \nWho is this forum for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nClick here to watch the recording of this session. \n“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits\nNotified Bodies (NBs) across Europe along with global manufacturers are facing resource constraints. The cause? Additional requirements imposed by the new MDR/IVDR Regulations. Team-NB\, the European notified body association\, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines. \nThe primary concern cited is the likely device shortage for patients. More complex and longer certification processes required under MDR/IVDR are influencing this shortage. In conjunction\, the demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs). With only 25 NBs for MDR and 6 for IVDR\, the demand outweighs supply. Compared with 51 NBs designated for MDD and 21 under the AIMDD/IVDD Directives\, manufacturers are in a tough situation now compared to years prior. \nTeam-NB identified the following four primary contributing factors\, summarized in our recent blog post here.
URL:https://criterionedge.com/event/ask-the-expert-tips-to-avoid-common-notified-body-review-findings/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ATE-Notified-Body-review-findings-cover-042822.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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