✅ Startups finalizing their Medical Device or SaMD for submission
✅ Companies requiring regulatory filing (MDR, IVDR, 510(k), De Novo, PMA, etc.)
✅ Startups undergoing clinical evaluation or validation testing
✔AI-Driven Documentation Automation
✔Pre-Submission Consultation (FDA Q-Sub, Notified Body Early Interaction)
✔ Pre-Audit Readiness Check– Detect & correct compliance gaps before official review
✔Clinical Evaluation & Performance Studies Support
✔ Full implementation of eQMS and ISO13485 certification support
✔Regulatory Submission Assistance
✔ Regulatory & Notified Body Review Support