Practical Insight into an IVDR QMS Audit: Preparation, Conduct & Outcomes

Recorded on November 30, 2021

Ioannis Bekatoros, Senior Regulatory Affairs Officer/Ad Interim QARA Manager
Tosoh Bioscience

• Steps taken to ensure IVDR QMS audit readiness
• On-site audit experience & areas of focus from the NB
• Specifics as an Authorized Rep for a Japanese organization
• IVDR QMS audit findings & remediation strategies
• Lessons learned from the manufacturer’s standpoint

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TARGETED AUDIENCES
Regulatory
Clinical
Performance Evaluation
Quality Assurance
IVDR

INDUSTRIES REPRESENTED
Diagnostics

Presenters:

Ioannis Bekatoros
Senior Regulatory Affairs Officer/Ad Interim QARA Manager
Tosoh Bioscience

Ioannis Bekatoros is currently the QARA Manager and IVDR Project Lead for Tosoh Europe’s diagnostics division and has broad experience in IVD international regulatory affairs, having developed and implemented regulatory strategies.
Prior to Tosoh, Ioannis spent 8 years at Thermo Fisher Scientific where he held positions in Quality Assurance and Regulatory Affairs.

For More Information, Contact:

Brooke Akins
Division Director, Life Science Programs
+1 (312) 224-1693
bakins@q1productions.com

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Archived Webinar

Practical Insight into an IVDR QMS Audit: Preparation, Conduct & Outcomes

Recorded on November 30, 2021

Ioannis Bekatoros, Senior Regulatory Affairs Officer/Ad Interim QARA ManagerTosoh Bioscience

Presenters:

For More Information, Contact:

Ioannis Bekatoros, Senior Regulatory Affairs Officer/Ad Interim QARA Manager
Tosoh Bioscience