BEGIN:VCALENDAR VERSION:2.0 PRODID:-//ChamberMaster//Event Calendar 2.0//EN METHOD:PUBLISH X-PUBLISHED-TTL:P1H REFRESH-INTERVAL:P1H CALSCALE:GREGORIAN BEGIN:VTIMEZONE TZID:America/New_York BEGIN:DAYLIGHT RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU DTSTART:20070101T000000 TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:Eastern Daylight Time END:DAYLIGHT BEGIN:STANDARD RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU DTSTART:20070101T000000 TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:Eastern Standard Time END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20210211T110000 DTEND;TZID=America/New_York:20210211T120000 X-MICROSOFT-CDO-ALLDAYEVENT:FALSE SUMMARY:RQM+ DEVICE L❤️VE Live! #28 Overcoming Challenges with Integrating PMS\, CERs/PERs and Risk Management under EU MDR and IVDR DESCRIPTION:The MDR and IVDR have significantly increased requirements for clinical\, regulatory\, and post-market surveillance documentation. To make it even more challenging\, there are overlapping requirements resulting in the need for consistent information across a variety of plans and reports. The integration of clinical\, regulatory\, risk management and post market surveillance is a difficult and confusing task\, however\, it's essential to ensure consistent information across all plans and reports: CEP/PEP\, CER/PER\, risk management file\, labeling\, PSUR\, PMCF/PMPF\, and SSCP/SSP. Our experts will discuss how the data inputs and outputs for these documents are interrelated and provide guidance and best practices on how to share information throughout the organization to streamline processes and ensure consistency. Amie Smirthwaite\, Ph.D. - Head of Clinical Regulatory Affairs\, RQM+ Nancy Morrison\, RAC - Executive Director\, Regulatory and Quality Consulting Services\, RQM+ Jon Gimbel\, Ph.D. - Executive Director\, Regulatory and Quality Consulting Services\, RQM+ DEVICE L❤️VE Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics\, challenges\, and solutions in the medical device and diagnostics industries. The panelists also answer audience questions. Every episode is added to our podcast\, too.REGISTER HERE X-ALT-DESC;FMTTYPE=text/html:
The MDR and IVDR have significantly increased requirements for clinical\, regulatory\, and post-market surveillance documentation. To make it even more challenging\, there are overlapping requirements resulting in the need for consistent information across a variety of plans and reports. The integration of clinical\, regulatory\, risk management and post market surveillance is a difficult and confusing task\, however\, it'\;s essential to ensure consistent information across all plans and reports: CEP/PEP\, CER/PER\, risk management file\, labeling\, PSUR\, PMCF/PMPF\, and SSCP/SSP. \;
Our experts will discuss how the data inputs and outputs for these documents are interrelated and provide guidance and best practices on how to share information throughout the organization to streamline processes and ensure consistency. \;
DEVICE L❤️VE Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics\, challenges\, and solutions in the medical device and diagnostics industries. The panelists also answer audience questions. Every episode is added to our podcast\, too.
LOCATION: UID:e.1244.318991 SEQUENCE:3 DTSTAMP:20240328T220345Z URL:https://business.massmedic.com/events/Details/rqm-device-l-ve-live-28-overcoming-challenges-with-integrating-pms-cers-pers-and-risk-management-under-eu-mdr-and-ivdr-305110?sourceTypeId=Hub END:VEVENT END:VCALENDAR