News and regulatory intelligence

What changed in FDA's nIVD eSTAR v7.0 — Human Factors, Clinical Evidence, QMSR alignment, pediatric indications and De Novo — and what it means mid-submission.

Being in charge of a regulatory submission for a medical device means managing a complex project with various moving parts and several contributors. If mismanaged, not only does the project face delays but your regulatory submission could get rejected.

And honestly… I didn’t fully appreciate that until I started sitting in on more regulatory conversations.

Essenvia CEO Soumya Mahapatra's five takeaways from RAPS Euro Convergence 2024: MDR and IVDR, digital transformation, RIM adoption, AI, and real-world evidence.

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 RAPS Convergence 2023, held in Montreal, went incredibly well. The event was perfectly organized, and industry experts had essential knowledge to share.

Starting October 2023, MedTech regulatory affairs teams will have only one way to file FDA 510(k) submissions for their medical devices electronically via the new eSTAR format. Only PMA submissions will be exempted from this requirement.

We’re thrilled to announce that we’ve raised a $4M Pre Series A with Wavemaker360 and Benhamou Global Ventures, with participation from existing investors First Rays, Rebright partners, as well as Pasadena Angels – all to help supercharge MedTech regulatory submissions.

Essenvia was born out of a need to streamline the regulatory process throughout the entire lifecycle of a medical device.