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
• 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
Pricing $249 for 1, $395 for up to 3 people
Senior Regulatory Affairs Officer/Ad Interim QARA Manager
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:
Division Director, Life Science Programs
+1 (312) 224-1693