Certification by Engineering Simulation

The focus of this ASSESS Initiative theme, launched in August 2024, is to advocate for and enable the expansion of the use of engineering simulation for the certification of products and processes as a critical objective for multiple industries, including biomedical, aerospace, and automotive. Examples include:

• The FDA collaborated with ASME to develop the ASME V&V 40 standard to enable certification by engineering simulation for FDA approval of medical devices, considering engineering simulation as an additional pillar of evidence.
• The Aerospace industry is working on enabling certification supported by simulation for aircraft, space vehicles, and associated systems. NASA (NASA/CR-20210015404) and the AIAA (R-154-20) have published guidance on certification and qualification by analysis. In the UK, Regulatory Article 5812 (RA 5812) describes digital models and simulations supporting airworthiness-related decision-making for military airworthiness.
• The automotive and transportation industries are working on homologation supported by simulation for the higher levels of autonomous vehicles.

Building on the NAFEMS Certification by Simulation webinar series, this ASSESS theme will explore the issues and approaches associated with certification by engineering simulation efforts to provide understanding and guidance for various industries.