BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T072539Z UID:1ccad9b8-3667-46ec-81ea-aefd0b30d642 DTSTART:20211028T090000 DTEND:20211029T090000 CLASS:PRIVATE DESCRIPTION:
Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2020 emphasizes this problem . Manufacturers must identify their roles\, identify the regulatory requir ements for that role\, and incorporate them into the quality management sy stem.
\n\nThe various jurisdictions\,
however\, deal with post-market device issues in many different ways. The
quality management system\, QMS\, needs three interlocking process: compl
aint management\, adverse event reporting\, and recalls. These processes a
lso have supporting QMS processes such as corrective action and design cha
nges. Overarching the QMS processes are the regulatory requirements\, usua
lly involving record keeping and reporting. This workshop covers these pri
mary and secondary QMS processes and analyzes them in terms of US\, EU\, a
nd Canadian regulations.
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To have an effective and efficient
QMS you need to understand how to implement the related QMS processes. Dev
eloping the processes involves implementing best practices\, but that does
n�t necessarily meet all the regulatory requirements. With the introduct
ion of ISO 13485:2020\, the Medical Device Single Audit Program (MDSAP)\,
and the new EU Medical Device Regulation\, you will need to update your QM
S and integrate all of the elements to assure an effective and compliant i
mplementation. This workshop provides the tools you will need.
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