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DTSTART;TZID=America/Los_Angeles:20211020T110000
DTEND;TZID=America/Los_Angeles:20211020T114500
DTSTAMP:20211021T213152Z
CREATED:20210813T032002Z
LAST-MODIFIED:20211021T213152Z
UID:2765-1634727600-1634730300@criterionedge.com
SUMMARY:[Ask the Expert] Performance Evaluation Report
DESCRIPTION:This session’s topic: The Performance Evaluation Report (PER)\nWith the implementation of IVDR requirements\, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance? \nDuring this 45-minute Q&A session\, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the role of the State-of-the-Art section within the PER\, whether using a PER template is right for you including what the notified body expects to see\, and the methodology and strategy for PER\, PEP\, and PMPF plans. \nWho should watch this webinar?\nRegulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. \nWatch the recording! \nWhat You Need to Be Compliant\nWatch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section\, and explain how it fits into the overall process of writing a successful\, IVDR-compliant PER. Additionally\, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources\, feeder documents\, and expertise needed to consider your IVD “state-of-the-art.” Ultimately\, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process. \nUltimately\, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it\, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.
URL:https://criterionedge.com/event/ask-the-expert-performance-evaluation-report-2/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-PER-102021.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20211006T110000
DTEND;TZID=America/Los_Angeles:20211006T114500
DTSTAMP:20211021T213522Z
CREATED:20210813T031751Z
LAST-MODIFIED:20211021T213522Z
UID:2762-1633518000-1633520700@criterionedge.com
SUMMARY:[Ask the Expert] Performance Evaluation Report
DESCRIPTION:This session’s topic: The Performance Evaluation Report (PER)\nWith the implementation of IVDR requirements\, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance? \nDuring this 45-minute Q&A session\, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the biggest pitfalls to look out for when writing a PER. In addition\, they discuss how to align your internal processes and systems to comply with rigorous IVDR regulations and what technical documents are required for the PER\, PEP\, and PMPF. \nWho should watch this webinar?\nRegulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. \nWatch the recording! \nWhat You Need to Be Compliant\nWatch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section\, and explain how it fits into the overall process of writing a successful\, IVDR-compliant PER. Additionally\, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources\, feeder documents\, and expertise needed to consider your IVD “state-of-the-art.” Ultimately\, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process. \nUltimately\, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it\, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.
URL:https://criterionedge.com/event/ask-the-expert-performance-evaluation-report/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-PER-100621.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210922T100000
DTEND;TZID=America/Los_Angeles:20210922T104500
DTSTAMP:20211021T214556Z
CREATED:20210813T023130Z
LAST-MODIFIED:20211021T214556Z
UID:2758-1632304800-1632307500@criterionedge.com
SUMMARY:[Ask the Expert] Safety and Performance
DESCRIPTION:This session’s topic: Safety and Performance Measures and Acceptance Criteria\nDo you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? \nDuring this 45-minute Q&A session\, our President Laurie Mitchell answers questions on how to identify meaningful safety and performance endpoints. In addition she discusses how to demonstrate that S&P endpoints are appropriate and clinically relevant​\, as well as how to specify acceptance criteria to determine the acceptability of benefit-risk. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Clinical Evaluation Reports for EU MDR or IVDR submissions \nWatch the recording! \nClearly Defining Measurable Safety and Performance Endpoints\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.   \nThese relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally\, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently\, medical device manufacturers felt the pressure to comply by May 2021. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ask-the-expert-safety-and-performance/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-s-p-measures-092221.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210915T110000
DTEND;TZID=America/Los_Angeles:20210915T120000
DTSTAMP:20211021T214832Z
CREATED:20210729T221916Z
LAST-MODIFIED:20211021T214832Z
UID:2507-1631703600-1631707200@criterionedge.com
SUMMARY:How to Establish the Competitive Landscape Within the Scientific Validity Report
DESCRIPTION:In this practical presentation\, Dr. Sarah Chavez\, presents a detailed outline of the 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 watch the recording?\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. \nWatch the recording! \nBuilding a Solid Foundation for your PER to Support IVDR Readiness\nWatch our recent webinar where we present an overview of the State of the Art section. Namely\, we explain how it fits into the overall process of writing a successful\, IVDR-compliant Performance Evaluation Report (PER). In addition\, a complete readiness assessment and gap analysis will help you identify critical resources\, feeder documents\, and expertise needed establish your IVD as “state-of-the-art.” Ultimately\, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process. \nYou will learn: \n\nThe importance of planning and preparation before you even begin to write the SOA\nThe complete outline of the SOA literature review and assessment process to understand “documentation” needs and what the Notified Body may be expecting to see as part of the Scientific Validity Report (SVR)\nThe potential impact  of incorrect/incomplete documents or processes\n\nTo watch the free webinar recording\, State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness\, click here.
URL:https://criterionedge.com/event/how-to-establish-the-competitive-landscape-within-the-scientific-validity-report/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/competitive-landscape-cover-with-date.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210901T110000
DTEND;TZID=America/Los_Angeles:20210901T114500
DTSTAMP:20220324T235804Z
CREATED:20210811T195140Z
LAST-MODIFIED:20220324T235804Z
UID:2722-1630494000-1630496700@criterionedge.com
SUMMARY:[Ask the Expert] Systematic Literature Review
DESCRIPTION:This session’s topic: Systematic Literature Review: What is it and why is it so important?\nDo you have specific questions about the steps of the systematic literature review process or questions regarding your medical device or IVD? During this 45-minute Q&A session\, our President Laurie Mitchell answers questions about the steps to conduct a methodologically sound SLR​​. In addition\, she discusses how to leverage published data to meet regulatory expectations and inform internal decision-making from marketing initiatives and clinical strategies to global regulatory requirements. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Systematic Literature Reviews for EU MDR or IVDR submissions\, meta-analyses\, regulatory response support\, development of clinical marketing materials\, etc. \nWatch the recording! \nWatch Our Related Webinar for an In-Depth Look at the SLR Process\nWith the implementation of IVDR and MDR requirements\, device manufacturers often struggle to align their internal processes and systems to comply with these rigorous regulations. Consequently\, companies realize the need to review published literature for device-specific clinical data. However many manufacturers may not be familiar with or have the capability to perform all steps of the rigorous systematic literature review process\, including screening\, selection and data extraction.  \nWatch our webinar where we break down the steps of the SLR process and take 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). We encourage professionals from the medical device industry to watch as well\, as the content is also relevant to MDR requirements\, which align closely with IVDR.
URL:https://criterionedge.com/event/systematic-literature-review-what-is-it-and-why-is-it-so-important/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ask-the-expert-SLR-090121.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
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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