Device Development Using In-Silico Techniques within an FDA Framework

14:40 - 15:15

  • Solving some of the industry’s most complex device design challenges using In-Silico (virtual) techniques
  • Reporting of computational modelling within an FDA regulatory submission - FDA V&V40
  • Digital evidence and the digital twin
  • Acoustic design and simulation
  • Will modelling and simulation ever be accepted as credible evidence of safety or clinical benefit?

 

 

Stephen Gilmore, Engineering Director, Crux Product Design