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:20260603T100000 DTEND;TZID=America/New_York:20260603T110000 X-MICROSOFT-CDO-ALLDAYEVENT:FALSE SUMMARY:What key decisions are needed when planning Clinical Evidence for the US and EU Medical Device Market? DESCRIPTION:When a medical device's risk profile requires clinical investigations\, early decisions regarding clinical evidence requirements\, study design\, market prioritization and regulatory engagement can significantly influence development timelines\, regulatory acceptance and overall US and EU market entry strategy. Clinical investigations can be complex\, time-consuming\, and expensive\, so strategic planning early in design and development is essential.In this webinar\, our speaker\, Maria E. Donawa\, M.D.\, will examine key strategic decisions involved in planning clinical evidence for US and EU medical device market entry.Attendees will gain a practical framework for planning clinical evidence strategies that support effective and efficient US and EU medical device market entry.Key takeaways:Key considerations for identifying US and EU clinical evidence requirements early in design and developmentKey considerations in determining which safety and performance requirements need clinical dataWhen multi-stage clinical investigations may be needed (e.g.\, first-in-human\, pilot\, pivotal)When to prioritize US vs. EU market entry and how that decision impacts clinical evidence strategyHow to address differing US and EU expectations for clinical evidence quality and acceptabilityWhen and how to engage FDA and EU Notified Bodies as part of clinical evidence strategy X-ALT-DESC;FMTTYPE=text/html:

When a medical device&rsquo\;s risk profile requires clinical investigations\, early decisions regarding clinical evidence requirements\, study design\, market prioritization and regulatory engagement can significantly influence development timelines\, regulatory acceptance and overall US and EU market entry strategy. Clinical investigations can be complex\, time-consuming\, and expensive\, so strategic planning early in design and development is essential.

In this webinar\, our speaker\, Maria E. Donawa\, M.D.\, will examine key strategic decisions involved in planning clinical evidence for US and EU medical device market entry.

Attendees will gain a practical framework for planning clinical evidence strategies that support effective and efficient US and EU medical device market entry.

Key takeaways:

Key considerations for identifying US and EU clinical evidence requirements early in design and development
Key considerations in determining which safety and performance requirements need clinical data
When multi-stage clinical investigations may be needed (e.g.\, first-in-human\, pilot\, pivotal)
When to prioritize US vs. EU market entry and how that decision impacts clinical evidence strategy
How to address differing US and EU expectations for clinical evidence quality and acceptability
When and how to engage FDA and EU Notified Bodies as part of clinical evidence strategy

LOCATION: UID:e.1244.1478670 SEQUENCE:3 DTSTAMP:20260603T144925Z URL:https://massmedic.growthzoneapp.com/events/Details/what-key-decisions-are-needed-when-planning-clinical-evidence-for-the-us-and-eu-medical-device-market-1752363?sourceTypeId=Hub END:VEVENT END:VCALENDAR