FREE ON-DEMAND WEBINAR 13th Dec, 2023 3:00 PM - 4:00 PM GMT

The Role of the Person Responsible for Regulatory Compliance (PRRC) Webinar

On Wednesday, December 13th 2023 we hosted a free Webinar on the Role of the Person Responsible for Regulatory Compliance (PRRC) under the European Medical Device Regulation (EU MDR 2017/745) and European In Vitro Diagnostic Regulation (EU IVDR 2017/746) from 3-4pm GMT.

Michelle has a proven track record with 15+ years’ experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.

This Webinar discussed key topics including:

👉 Current Status of the PRRC
👉 Implementation of the PRRC into the organization and the QMS
👉 How Notified Bodies are assessing the role of the PRRC in Audits
👉 Where are most non-conformities observed when auditing the role of the PRRC
👉 PRRC – Internal vs External
👉 Q&A

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Michelle has a proven track record with 15+ years’ experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.

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