Using AI to Empower Device Makers

Trusted Partner in your Post-Market Surveillance Journey

Our mission at empowerreg is to lead the revolution in Regulatory Operations Management (ROMS) for medical device makers and developers. By integrating deep regulatory expertise with advanced AI/Gen AI, our ROMS platform not only revolutionizes surveillance and compliance we also empower companies to excel and compete globally.

We solve hard problems that others don't

Struggle with complex regulatory requirements across product development, post-market surveillance, and remediation, particularly with FDA and European Commission standards.
Rely on mountains of fragmented and noisy data, manual systems that lead to inefficiencies, including poor data management, lack of automation, and weak analytics capabilities.
Face significant risks such as extremely high operational costs, delays in product launches, and potential loss of market access due to non-compliance.