Generating Regulatory-Ready Digital Evidence with Simulation-Driven Design

Medical device developers face growing pressure to deliver safer, more complex products while reducing cost, time to market, and regulatory risk. This white paper explains how simulation-driven design enables teams to generate credible digital evidence using physics-based digital twins across the full device lifecycle. It outlines how simulation supports better design decisions, faster validation, and earlier regulatory confidence without relying solely on physical testing.

What You’ll Learn

• How physics-based simulation enables digital evidence generation before bench or clinical testing
• How regulators, including the FDA, support credible simulation as part of regulatory submissions
• How simulation applies across fluids, structures, electronics, and system-level behavior in medical devices
• The four characteristics—realism, design exploration, speed, and continuity—that maximize simulation value

Why It Matters

• Reduces development cost and timelines by minimizing physical prototypes and late-stage redesigns
• Strengthens regulatory submissions with validated, traceable digital evidence tied to design history
• Improves product quality and patient safety through earlier, physics-informed design decisions

Download the full white paper to learn how simulation-driven design helps medical device teams generate digital evidence, accelerate development, and support regulatory approval.

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