Unannounced Audits under the new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR)

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Unannounced Audits under the new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR)While waiting for the publication of the new regulation, which is expected in Q1 2017, medical device and IVD manufacturers are still subject to random unannounced factory inspections by Notified Bodies at least once every three years. The goal of unannounced audits is to assure day-to-day compliance of the manufacturer’s product and quality management systems (QMS).

Download and find out:

  • The difference between surveillance audits and unannounced audits
  • Current requirements for unannounced audits
  • Key preparation actions for a successful unannounced audit

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