Strategy

​​Bringing AI-enabled healthcare software products to market, such as such as Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) as well as Clinical Decision Support Systems (CDS), requires navigating the complex and evolving US Food and Drug Administration (US FDA) regulatory landscape. Staying compliant throughout the entire product life cycle is crucial for achieving successful market entry and long-term performance.

 

At EvidenceX, we simplify this journey. We specialize in regulatory strategy, clinical assessment strategy, and data-driven decision-making to help you:

• Accelerate market entry: Navigate the FDA review process efficiently, minimizing delays.

• Reduce regulatory risk: Mitigate potential roadblocks and ensure compliance with evolving regulations of digital heatlh and AI.

• Maximize product success: Focus on generating robust clinical evidence and building a strong foundation for long-term market success.​​​​​​

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Founded by Dr. Subok Park, a seasoned regulatory strategist with over 20 years of experience at the FDA and in the AI-enabled medical device industry, EvidenceX offers unparalleled expertise in:

• SaMD and CDS product development

• Early-stage regulatory planning

• Clinical study design and execution

• Post-market updates via Pre-determined Change Control Plan (PCCP)​​

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Ready to bring your AI-powered healthcare innovation to market with confidence?  Contact us today for a free initial consultation or explore our services to learn more.