Regulatory Resources

FDA’s nIVD eSTAR v7.0 introduces important updates for Human Factors, Clinical Evidence, QMSR alignment, pediatric indications, and De Novo submissions. Learn what changed and how Essenvia helps regulatory teams build faster, cleaner, review-ready eSTAR submissions.

Regulatory affairs teams are being asked to move faster, reduce manual work, and accelerate market access while managing increasing regulatory complexity. This RAPS Euro Convergence presentation shows how MedTech RA teams can use regulatory AI to achieve measurable value quickly, build trust, and scale responsibly.

For regulatory teams navigating the ever-evolving landscape of the MedTech industry, a Regulatory Intelligence platform isn't just a “nice to have” —it's an absolute necessity! Let's explore why MedTech regulatory teams shouldn't operate without the guiding light of regulatory intelligence.

The Top 5% Playbook: Prepare your Regulatory Affairs team for a successful AI RIMS rollout