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DTSTART;TZID=America/Los_Angeles:20210825T110000
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UID:2494-1629889200-1629892800@criterionedge.com
SUMMARY:Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
DESCRIPTION:Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance\nIn this presentation we discuss strategies for the verification of device safety and performance in the clinical evaluation. Our seasoned CER medical writers are rooted in MDR-compliant practices. Likewise\, this presentation will help you identify meaningful safety and performance measures for the clinical evaluation. In addition\, we will define parameters to determine the acceptability of benefit-risk. Afterwards\, we will have about 10-15 minutes to answer any questions you may have on this topic. \nWho should watch the recording?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve CERs for EU MDR submission. Anyone interested in learning more about MDR requirements for CERs is encouraged to come too. We encourage attendees from the IVD industry to attend as well\, as the content is also relevant to IVDR requirements\, which align closely with MDR. \nWatch the recording! \nClearly Defining Measurable Safety and Performance Endpoints\nAll medical devices selling in Europe must have a Clinical Evaluation Report (CER). Specific and measurable safety and performance endpoints are paramount for an acceptable CER. However\, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints\, especially in the literature review\, to support an evidence-based evaluation.  \nThe newest regulations for medical devices\, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4\, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously\, regulations under the old MDR and MEDDEV were not as demanding. Also\, manufacturers are not accustomed to the current systematic process of CER evaluations. Read more on this topic in our recent blog post\, here. \nWant to read the highlights to verifying your device’s safety and performance? Download our white paper where we give your the best approaches to finding measurables objectives and acceptance criteria for your medical device.
URL:https://criterionedge.com/event/clinical-evaluation-measurable-objectives-and-acceptance-criteria-to-verify-device-safety-and-performance/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/1.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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DTSTART;TZID=America/Los_Angeles:20210826T110000
DTEND;TZID=America/Los_Angeles:20210826T113000
DTSTAMP:20211021T215555Z
CREATED:20210813T011516Z
LAST-MODIFIED:20211021T215555Z
UID:2740-1629975600-1629977400@criterionedge.com
SUMMARY:[Ask the Expert] The Importance of Clinical Data
DESCRIPTION:This session’s topic: The Importance of Clinical Data: Sources of Data\, Literature Searches\, Weighting & Appraisal and Effective Presentation in your CER or PER\nDuring this 30 minute Q&A session\, our President Laurie Mitchell answers questions on how to generate\, analyze\, and assess clinical data pertaining to your IVD or medical device. In addition\, she discusses the best practices for conducting literature searches and how to effectively present your data in your Clinical Evaluation Report or Performance Evaluation Report. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve clinical evaluation reports or performance evaluation reports for EU MDR or IVDR submissions. \nWatch the recording! \nHow to Empower Data-Driven Decisions in Your Organization\nEvery day\, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform\, direct\, and help drive their internal processes and decisions. Of course\, clinical literature is also required for compliance with global regulatory requirements. Conducting SLRs to search\, screen\, and extract data from published sources can present challenges to your team in terms of expertise (e.g.\, medical librarian)\, methodology\, and resources. It takes trained people with the availability to screen\, review\, and analyze the literature. \nDownload our free white paper\, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic. \nYou can also watch our webinar on this topic. \nOur President Laurie Mitchell joins Jennifer Tetzlaff\, Research Product Specialist with Evidence Partners\, to talk to you about the following points: \n\nExamples of how the use of published data can support regulatory expectations\nWhen to conduct a systematic literature review\nBest practices for conducting a methodologically-sound SLR\nUse of available tools and technology
URL:https://criterionedge.com/event/ask-the-expert-the-importance-of-clinical-data/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-clinical-data-082621.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
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