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UID:69e4b186bf450@leapup.bitshifters.cloud
DTSTAMP:20260419T124214Z
DTSTART:20210622T140000Z
DTEND:20210622T170000Z
SUMMARY:PRRC – Person Responsible for Regulatory Compliance Article 15 MDR (EU) 2017/745 and IVDR (EU) 2017/746
DESCRIPTION:Training objectives:&bull\; Understand the regulatory context of PRRC roles and responsibilities&bull\; Understand the qualification needed to select the PRRC within your company&bull\; Understand in what particular situation the role of the PRRC can be outsourced&bull\; Analyse the impact on the QMS documentation\nTraining content:&bull\; Regulatory context\n\nReview of Article 15 requirements\nRequirements regarding PRRC&rsquo\;s qualification\n\n&bull\; Implementation of the requirements\n\nAnalysis of the roles and responsibilities of the PRRC\nHow to implement in practice the requirements of Article 15\nOutsourcing and sharing the roles and responsibilities of the PRRC\nLiability\n\n&bull\; Impact on QMS documentation\n\nJob description\nQuality Manual\nHuman Resources process\nPos-market Surveillance and Vigilance processes\nDesign and Development and Manufacturing processes\n
LOCATION:Online\, Lausanne
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