FDA Related Advisory

A healthcare professional wearing a green surgical gown, mask, glasses with a green frame, a hairnet, and gloves working at a computer in a medical office or hospital.

21 CFR Part 11 Compliance

We help companies:

  • Assess current systems for regulatory gaps.

  • Establish compliant procedures for electronic records, audit trails, and user management.

A woman sitting at a control panel in a hospital monitoring room, observing an MRI scan of a patient lying down inside the MRI machine through a glass window.

510(k) Premarket Preparation

Streamline your submissions with:

  • Strategic planning and regulatory pathway analysis.

  • Preparation or review of software documentation and cybersecurity.