Medical Device & Diagnostics Summit – Agenda

*Agenda subject to change.

Monday, June 1, 2020

6:00 p.m. – 8:00 p.m.
Welcome Reception Offsite

Tuesday, June 2, 2020

7:00 AM – 8:15 AM
Breakfast
8:30 AM – 9:30 AM
Keynote
9:30 AM – 4:00 PM
Breakout Sessions

CLINICAL | Modernize Clinical Operations
  • Clinical Transformation – From the Laboratory to the Clinic
  • Actionable TMF Best Practices
  • Real-World Evidence and How to Apply It
  • Global Clinical Management Transparency
  • Best Practices When Outsourcing Your Clinical Trials

REGULATORY | Transform Your Regulatory Process
  • Beyond MDR: Global Regulatory Transformation
  • Preparing for IVDR – What’s the Plan?
  • Closing the Compliance Gaps for Your Regulated Content
  • Expanding Promotional Content Globally

QUALITY | Elevating Quality Beyond Compliance
  • QualityDocs as the First Step in QMS Transformation
  • Unifying Commercial, Regulatory, and Quality: Maximizing Return on Investment Throughout the Value Chain
  • Modernizing Quality Management: A Journey from Legacy Systems to the Cloud
  • The Case for Quality (CfQ): Impact to the Medical Device Industry
  • #makeCAPAcool: An Industry Initiative to Streamline & Optimize CAPA Process
4:00 PM – 6:00 PM
Farewell Reception (optional)