BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Criterion Edge - ECPv6.18.2//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://criterionedge.com
X-WR-CALDESC:Events for Criterion Edge
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Los_Angeles
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20210314T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20211107T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20220313T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20221106T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20230312T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20231105T090000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220209T110000
DTEND;TZID=America/Los_Angeles:20220209T114500
DTSTAMP:20220301T215212Z
CREATED:20220207T201845Z
LAST-MODIFIED:20220301T215212Z
UID:3292-1644404400-1644407100@criterionedge.com
SUMMARY:[Ask the Expert] Safety and Performance (MDR)
DESCRIPTION:This session’s topic: Safety and Performance Measures and Acceptance Criteria for MDR\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? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk? \nThis is a 45-minute Q&A session during which President Laurie Mitchell will answer questions like these and more. Submit your questions when you register for this forum. Please be aware that answers will be limited to 3 minutes per questions. This forum will operate on a first come first serve basis. \nWho is this forum for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Clinical Evaluation Reports for EU MDR submissions \nClick here to watch 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-4/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220223T110000
DTEND;TZID=America/Los_Angeles:20220223T120000
DTSTAMP:20220224T183558Z
CREATED:20220208T231550Z
LAST-MODIFIED:20220224T183558Z
UID:3300-1645614000-1645617600@criterionedge.com
SUMMARY:IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation
DESCRIPTION:IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation\n\nIn this webinar\, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First\, we know a PER has many moving pieces. Accordingly\, we’ll present strategies to keep you and your team on track and help assess your own level of preparedness. Next\, using our CE Scoping checklist\, we will walk through the essential IVDR documents. Additionally\, we’ll discuss SOPs\, processes\, reports\, and templates\, and explain how each of these fits into the overall process of preparing to write. \nGoals for this webinar:\n\nEmphasize the importance of scoping\nDiscuss how to develop a checklist\nIllustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process\n\nWho should watch this webinar? \nThose Regulatory\, Quality and Clinical leaders and teams who are tasked with the development\, writing\, review or approval of performance evaluation reports for IVDR submissions. \nClick here to watch the recording of this webinar. \nLeveraging the MDR Experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMCF Processes\nWatch our free webinar where Laurie Mitchell and Caroline Byrd discuss and share key “lessons learned” from their years of experience supporting medical device manufacturers in the transition from MDD to MDR and current IVD companies transition to IVDR compliance. How can the insights gained from the MDR experience support and inform IVD companies as they transition to IVDR? \nKey takeaways from the discussion include: \n\nEarly implementation of structural process change across the organization can empower future success with IVDR submissions to the notified bodies\nWhat are the key documents and processes essential for successful alignment with IVDR regulations\nThe importance of understanding the critical role of proactive and ongoing Systematic Literature Review search and screening activities\nUnexpected roadblocks\n\n\n\nWho should watch this webinar?\nAll regulatory\, clinical\, and scientific professionals who develop\, write\, review\, or approve scientific manuscripts\, reports\, presentations\, and other forms of communications in the medical device\, pharmaceutical\, and diagnostics space. \nWatch the recording.
URL:https://criterionedge.com/event/ivdr-essentials-performance-evaluation-report-early-planning-and-preparation/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVDR-Essentials-cover-slide-022322.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
END:VCALENDAR