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DTSTART;TZID=America/Los_Angeles:20221005T110000
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DTSTAMP:20221006T215640Z
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SUMMARY:Ask the Expert: Clinical Evaluation Report Critical Concepts
DESCRIPTION:Ask the Expert: Clinical Evaluation Report Template and Critical Concepts\nThis 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\, and risk-benefit ratio. We hope to provide you with best practices and writing strategies to support solid planning during your own writing process. \nDuring this session\, come prepared with your questions for our experts to answer. Please submit your questions ahead of time while registering for this session 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. \nClick here to watch the recording of this session. \nWho is this session 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. \nHow to Deploy Systematic Literature Review in Order to Augment Post Market Clinical Surveillance\nAre you looking for best tips on how to create a robust systematic literature review process? And maybe even an informative case study illustrating the process? Watch our webinar on effective systematic literature review for post-market surveillance to understand how to continually support your device once your clinical evaluation report is completed and submitted. Learn how leveraging published data can help meet regulatory expectations and inform internal decision-making​\, the steps for conducting a methodologically-sound SLR​\, and even how data obtained through SLR can empower the successful execution of post-market surveillance activities\, drive efficiencies\, and support regulatory compliance. \nKey Strategies to Support Project Success: The Clinical Evaluation Report Template\nDo you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant? \nDownload our free white paper\, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
URL:https://criterionedge.com/event/ask-the-expert-clinical-evaluation-report-critical-concepts/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
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ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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DTSTART;TZID=America/Los_Angeles:20221026T110000
DTEND;TZID=America/Los_Angeles:20221026T120000
DTSTAMP:20221027T213857Z
CREATED:20221006T233131Z
LAST-MODIFIED:20221027T213857Z
UID:3928-1666782000-1666785600@criterionedge.com
SUMMARY:Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency
DESCRIPTION:Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency\nIn 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 under MDD/AIMDD\, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data. \nAdditionally\, we will touch on some examples of the types of clinical data that are appropriate to use for “legacy devices” for both MDR and IVDR requirements\, and finally we will review the MDCG 2020-6 guidance on clinical data for “legacy devices.” \nThere will be time at the end of the presentation to get your questions answered. Please submit your questions beforehand if you have any to help us prepare. You can also submit your questions during the presentation. \nClick here to watch the recording of this session. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions\, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant. \nPost Market Surveillance: Systematic Literature Review and Case Study\nJoining Criterion Edge’s President Laurie Mitchell\, is guest speaker\, Queenita Fernandes\, Medtronic’s Medical Safety Manager\, Patient Monitoring & Respiratory Interventions​. In this webinar\, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance\, and share best tips on a robust systematic literature review process. Following this\, our guest speaker shares an informative case study illustrating more. \nKey Takeaways: \n\nHow leveraging published data can help meet regulatory expectations and inform internal decision-making​\nSteps for conducting a methodologically-sound SLR​\nHow data obtained through SLR can empower the successful execution of post-market surveillance activities\, drive efficiencies and support regulatory compliance.\n\nWatch this free webinar here.
URL:https://criterionedge.com/event/critical-concepts-the-role-of-post-market-surveillance-in-establishing-data-sufficiency/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
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ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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