In-silico Device Certification

Our company specializes in biomechanics and finite element analysis, providing high-value expertise across all stages of the medical device R&D lifecycle—from early design to regulatory validation.

🔬 Our services include:

• Device design & optimization
  We conduct design studies for new devices based on initial concepts and specifications, as well as performance improvement studies for existing products.

• In-silico mechanical testing
  We perform advanced numerical simulations to significantly reduce the number of required physical tests. This approach helps identify critical scenarios, saving both time and development costs.

• Advanced biomechanical analysis
  Our simulations provide deep insight into mechanical behavior and potential failure modes under real conditions of use, enabling better risk anticipation and design validation.

• Regulatory-oriented validation (V&V)
  We evaluate simulation credibility in accordance with the ASME V&V40 standard (FDA-supported), ensuring that in-silico evidence can be reliably used within regulatory submissions.

🎯 Key benefits:

• Accelerate your certification timeline

• Reduce development and testing costs

• Strengthen your regulatory documentation

• Improve device safety and performance through predictive modeling