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DTSTART;TZID=America/Los_Angeles:20211103T110000
DTEND;TZID=America/Los_Angeles:20211103T114500
DTSTAMP:20211104T202232Z
CREATED:20210813T035040Z
LAST-MODIFIED:20211104T202232Z
UID:2768-1635937200-1635939900@criterionedge.com
SUMMARY:[Ask the Expert] The Importance of Clinical Data
DESCRIPTION:The Importance of Clinical Data: Sources of Data\, Literature Searches\, Weighting & Appraisal and Effective Presentation in your CER or PER\nDo you have questions about how to generate\, collect\, analyze\, and assess clinical data pertaining to your IVD or medical device? And what are the best practices for conducting literature searches? How do you effectively present your data in your clinical evaluation report or performance evaluation report? \nDuring this 45-minute Q&A session\, our President Laurie Mitchell is joined by Dr. Sarah Chavez  to answer some commonly asked questions and give expert advice. Answers cover how to best collect and present data on similar (competitor) devices as well as data collection strategies for new products. In addition\, there is discussion around best practices for and examples of appraising literature and clinical data. Also\, clarification between safety & performance metrics and risks & benefits analyses is given\, plus so much more. \nWatch the recording! \nWho should watch this forum?\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. \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\, to comply with global regulatory requirements\, clinical literature is also required. 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-2/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/SP-Measures-final-cover-with-date-11.17.21.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:20210902T110000
DTEND;TZID=America/Los_Angeles:20210902T114500
DTSTAMP:20211021T215036Z
CREATED:20210901T232210Z
LAST-MODIFIED:20211021T215036Z
UID:2846-1630580400-1630583100@criterionedge.com
SUMMARY:[Ask the Expert] Measurable Objectives and Acceptance Criteria
DESCRIPTION:This session’s topic: Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance\nAre you looking for strategies for the verification of device safety and performance in the clinical evaluation? Are you struggling to define device safety and performance objectives? During this 45-minute Q&A session\, our President Laurie Mitchell answers questions regarding how to identify meaningful safety and performance endpoints. In addition\, she discusses how to demonstrate safety and performance objectives are appropriate and clinically relevant as well as what acceptance criteria is and how to define it. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and regulatory writers who are tasked with the development\, writing\, review or approval of Clinical Evaluation Reports for EU MDR submission\, or anyone interested in learning more about MDR requirements for CERs. If you attended our hour-long webinar on August 25\, but we did not answer your questions we encourage you to attend to get your questions answered on this topic. \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.  \nRead more on this topic in our recent blog post\, Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers.
URL:https://criterionedge.com/event/ask-the-expert-measurable-objectives-and-acceptance-criteria/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20210825T110000
DTEND;TZID=America/Los_Angeles:20210825T120000
DTSTAMP:20220325T004943Z
CREATED:20210729T214539Z
LAST-MODIFIED:20220325T004943Z
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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