EvidenceX, LLC

EvidenceX, LLC specializes in regulatory and clinical assessment strategies for AI-enabled healthcare software products, including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and Clinical Decision Support (CDS) systems. Led by Dr. Subok Park, with over 20 years of experience in the FDA and the AI-enabled medical device industry, EvidenceX, LLC works directly with startups and small companies to navigate the complex US FDA regulatory landscape, helping them accelerate market entry, reduce risk, and maximize long-term success. Expert guidance is provided in the following areas: • Regulatory strategy assessment and gap analysis (for both overall regulatory strategy and FDA feedback response) • Product development aligned with FDA regulations • Early-stage regulatory planning • Clinical study design and execution • Post-market updates, including Pre-Determined Change Control Plans (PCCP) • FDA deficiency resolution and communication • Support for technical documentation for regulatory submissions Let EvidenceX, LLC help you navigate evolving regulations and bring your innovative healthcare products to market with confidence.