SERVICES
At EvidenceX, we offer expert guidance tailored to your unique regulatory and clinical needs. Whether you’re an early-stage startup or an established company, our services are designed to streamline your product’s pathway to market while ensuring compliance with the latest regulations. Â
Our key service areas include:
Regulatory Strategy
Develop a proactive regulatory strategy that identifies critical data requirements and key milestones from early product development through post-market phases. We help you anticipate regulatory hurdles and ensure your product meets the necessary evidentiary standards for a successful submission.
Performance Assessment Strategy
Develop a robust performance assessment framework to generate reliable evidence of your product’s safety and effectiveness. We help you design, execute, and interpret performance testing plans that meet regulatory expectations.
Product Development Strategy
Build a sound product development strategy that incorporates regulatory and clinical considerations from the start. We assist in integrating regulatory milestones into your product’s development life cycle to minimize risks and delays.
Clinical Assessment Strategy
Craft a comprehensive clinical assessment strategy that ensures your AI-enabled product meets clinical validation requirements. From study design to regulatory submissions, we provide support throughout the entire clinical evaluation process.
Gap Analysis
Identify gaps in your current regulatory, clinical, or product development strategies and processes. We provide actionable recommendations to bridge those gaps and optimize your regulatory strategy.
FDA Communication
Facilitate effective communication with the FDA, including pre-submission meetings, Q-Sub interactions, and formal submissions. In the event of regulatory deficiencies or questions, we support you in crafting comprehensive, well-reasoned responses that address regulatory concerns, expedite review timelines, and keep your product on track for market approval.
​Ready to move your AI-enabled healthcare product forward with confidence? Contact us today to schedule a free initial consultation and learn how EvidenceX can provide the expert support you need.