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DESCRIPTION:In this webinar\, learn how to implement the changes required 
 by the new regulation EU MDR 745/2017 in your current quality management 
 system in a simple and quick way. The information in this course is vital
  to your passing the Quality Management Audit by your certification compa
 ny or notified body.\n\nWhy Should You Attend:\n\nThe new medical device 
 regulation&nbsp\;EU MDR 745/2017&nbsp\;in the European Union has a lot of
  new requirements. One hot topic is the focus on the supply chain and the
  interfaces to the&nbsp\;EN ISO 13485:2016.&nbsp\;Both\, the ISO standard
  and the MDR requires for outsourced processes additional activities and 
 be careful with outsourced processes. Those are not only on the classic s
 upplier side. Those are also on the other side of the company in the area
  of sales and post market activities. The understanding of this changes a
 nd how to implement is essential to keep your certificates.\n\nYou should
  attend this webinar to understand\, what are the changes to the previous
  medical device regulation and how to implement the changes in your curre
 nt quality management system in a simple and quick way. Your implementati
 on need smart ideas to reach the right level to pass the quality manageme
 nt audit by your certification company or notified body.\n\nThe webinar w
 ill describe the following vital topics:\n\n\nIntroduction\, who must app
 ly the new EU MDR 745/2017 requirements\nOverview about the changes of th
 e EU MDR 745/2017 regarding supplier and outsourced activities.\nExplaini
 ng of each change\nSmart and fast ways to implement the changes in your q
 uality management system\nFast track internal audit to approve the change
 s\nWho is responsible for the activities?\nWhich (new) roles in the compa
 ny required?\n\nAreas Covered in the Webinar:\n\n\nCloser regulatory bind
 ing of the ISO to the new EU MDR\nResponsibilities for outsourced process
 es\nWhat are outsourced processes?\nAdjustments in the management review\
 nAdjustments in the audit process\nHow to onboard the supplier?\nExamples
  from outsourced R&amp\;D-\, manufacturing-\, lab-test - processes\nExamp
 les from outsourced sales processes\n\nWho Will Benefit:\n\nCEO’s\, purch
 asing manager\, quality/regulatory affairs manager\, quality representati
 ves of\n\n\nmedical device manufacturer\nimporter\ndistributors\ndealers\
 n\nwho work with European Union\, European Economic Area\, Switzerland\, 
 Turkey\n\n&nbsp\;\n
DTEND:20250113T110000
DTSTAMP:20260514T153501Z
DTSTART:20250113T100000
LOCATION:\,
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SUMMARY:In this webinar\, learn how to implement the changes required by t
 he new regulation EU MDR 745/2017 in your current quality management syst
 em in a s...
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