✅ 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

✅ Shortened time-to-market with automated compliance processes

✅ Reduced audit findings & delays

✅ Lower submission costs vs. traditional regulatory consultants

✅ Be ready to scale