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

Webinar on the Role of the PRRC under EU MDR and EU IVDR

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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