IEC 62304 and IEC 82304-1 - how to make them work

  • Challenges with Medical Device software
  • Changes in IEC 62304-1 ed 2.0
  • New standard for SaMD, software as Medical Device, IEC 82304-1
  • Health software – new scope for the software standards
  • EU - Regulatory changes affecting Medical Device software
  • US – Regulatory changes affecting Medical Device software
  • Q&A
Presented by: Robert Ginsberg