Free on-demand webinar

Ask an FDA Expert Anything

60-minute Q&A webinar

The FDA Group's Larry Stevens answers over 20 user-submitted questions covering FDA compliance, quality, and regulatory topics.

Topics include:

  • ISO 13485:2016
  • FDA guidelines regarding data integrity
  • MDR proactive actions
  • FDA inspection readiness
  • Clinical studies
  • Human failures & risk analysis
  • 510(k) for device modifications and innovations
  • Training employees for compliance
  • FDA audits
  • CAPA
  • Compliance for combination products
  • Regulatory harmonization
  • Post-market clinical follow-up studies
  • The future of QSR & ISO 13485

...and much more.

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