BEGIN:VCALENDAR VERSION:2.0 PRODID:-//ChamberMaster//Event Calendar 2.0//EN METHOD:PUBLISH X-PUBLISHED-TTL:P3D REFRESH-INTERVAL:P3D 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:99991231T000000 TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:Eastern Standard Time END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20200715T090000 DTEND;TZID=America/New_York:20200715T100000 X-MICROSOFT-CDO-ALLDAYEVENT:FALSE SUMMARY:Transition to European Medical Device Regulation – Ongoing Challenges DESCRIPTION:Join MassMEDIC and Boston MedTech Advisors for a discussion on potential opportunities and challenges to certification under the new MDR. About this Event Sweeping changes to the regulation of medical devices in Europe went into effect in May 2017\, with a 3-year transition period from MDD to MDR. However\, due to coronavirus\, the transition has been extended until May 2021\, giving companies more time to implement the new regulations.\n\n In this webinar\, some key issues related to the new MDR will be addressed\, including:Current status of notified body accreditation\; Clinical evaluations\, clinical data\, equivalence\; Changes in classification\; and Non-clinical challenges Authorized Representative (AR)\, Person Responsible for Regulatory Compliance (PRRC)\, Post Market Surveillance (PMS). Learn more X-ALT-DESC;FMTTYPE=text/html:

Join MassMEDIC and Boston MedTech Advisors for a discussion on potential opportunities and challenges to certification under the new MDR. \;

About this Event \;

Sweeping changes to the regulation of medical devices in Europe went into effect in May 2017\, with a 3-year transition period from MDD to MDR. However\, due to coronavirus\, the transition has been extended until May 2021\, giving companies more time to implement the new regulations.

 \;In this webinar\, some key issues related to the new MDR will be addressed\, including:

Current status of notified body accreditation\; \;

Clinical evaluations\, clinical data\, equivalence\; \;

Changes in classification\; \;

and Non-clinical challenges &ndash\; \;

Authorized Representative (AR)\, Person Responsible for Regulatory Compliance (PRRC)\, Post Market Surveillance (PMS). \;

Learn more

LOCATION: UID:e.1244.200854 SEQUENCE:3 DTSTAMP:20200815T132737Z URL:https://business.massmedic.com/events/Details/transition-to-european-medical-device-regulation-ongoing-challenges-220411?sourceTypeId=Hub END:VEVENT END:VCALENDAR