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UID:4835-1678273200-1678276800@criterionedge.com
SUMMARY:Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
DESCRIPTION:The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria\, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product\, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association with a clinical condition. But what is the purpose of the SVR\, and how should you approach it when there is too much or not enough data? \nThis webinar will discuss the role of data sufficiency\, the importance of developing a solid strategy to establish scientific validity\, how gaps in the SVR can significantly impact the quality of the PER\, and how proper scoping can help maximize success when it comes to a performance evaluation. \nIn this webinar\, you will learn\n1. How to clearly define what information should (and shouldn’t) be presented within the Scientific Validity Report.\n2. How the systematic literature review process supports and connects the SVR\, CPR\, and APR by leveraging published data.\n3. How to conduct gap assessments to assess IVDR readiness and develop strategies to increase efficiencies in the performance evaluation process to support the SVR. \nAt the end of the presentation\, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nWho should register for this webinar?\n\n\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve performance evaluation reports for IVDR submissions.\n\n\n\n\n\nClick here to watch the recording of this webinar. \nNew Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference\nIn October 2022\, the AAMI/FDA/BSI Annual Conference discussed current knowledge and practical strategies to meet new IVDR clinical evidence requirements. Dr. Sarah Chavez\, Criterion Edge Director of IVD Writing Services\, was invited to speak with other regulatory\, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”. \nWatch Dr. Chavez’s recent webinar and benefit from key insider insights gleaned from this meeting. Sarah shares and discusses the key take-aways from the Symposium\, including clinical evidence requirements and strategies to keep your report writing and data collection on track.  Many companies are in the early stages of planning for IVDR\, so take a step towards IVDR readiness with these helpful suggestions for planning and preparation from the perspective of experienced regulatory writers. \nWatch the webinar recording here.
URL:https://criterionedge.com/event/stay-focused-the-purpose-of-the-svr-and-tips-for-building-a-strong-per-foundation-3/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Stay-Focused-The-Purpose-of-the-SVR-03.08.23.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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DTSTART;TZID=America/Los_Angeles:20230315T110000
DTEND;TZID=America/Los_Angeles:20230315T120000
DTSTAMP:20230301T013115Z
CREATED:20230301T013115Z
LAST-MODIFIED:20230301T013115Z
UID:4836-1678878000-1678881600@criterionedge.com
SUMMARY:Critical Concepts Medical Device Software: Approaches to Determining Risk Classification\, Qualification\, and Safety and Performance Outcomes
DESCRIPTION:In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic\, the FDA released 4 guidance documents in 2022 alone\, on topics ranging from cyber security\, medical image devices\, and mobile medical applications. Furthermore\, the European MDR- EU 2017/745 and new IVDR – EU 2017/746 regulation contain stipulations related to how software is regulated\, classified\, and qualified. \nYou may be asking yourselves:\n– Is my software considered a medical device?\n– How do I address the clinical evaluation for my medical device software?\n– How do I define the safety and performance outcomes\, and other clinical evaluation parameters? \nJoin us for answers to these questions and to find out more about the topic of software as a medical device! \nWatch the recording of this webinar here. \nWho should register for this webinar?\n\n\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve clinical evaluation reports for MDR submissions.
URL:https://criterionedge.com/event/critical-concepts-medical-device-software-approaches-to-determining-risk-classification-qualification-and-safety-and-performance-outcomes-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Critical-Concepts-SaMD-031523.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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