Processes

What will AGI do for 510(k) and CE Submission Preparation?

Positioning for this Coordinate is coming soon.

How AGI delivers it

Four ways AGI delivers for 510(k) and CE Submission Preparation

  • Autonomous Agents as digital employees

    Hire a digital employee that does the job under earned, supervised autonomy.

    For 510(k) and CE Submission Preparation, hire a digital employee that does the job under earned, supervised autonomy.

  • Business-as-Code

    Encode how your work runs, once, as software that executes itself.

    For 510(k) and CE Submission Preparation, encode how your work runs, once, as software that executes itself.

  • Services-as-Software

    Get the professional outcome delivered as software, priced on results, not headcount.

    For 510(k) and CE Submission Preparation, get the professional outcome delivered as software, priced on results, not headcount.

Value flow

How 510(k) and CE Submission Preparation connects

automated by

  • Regulatory Information Management Systemsmodel

measured by

  • FDA Additional Information Request Ratemodel
  • Submission Clearance Timemodel

produces

  • 510(k) Premarket Notificationmodel
  • CE Technical Documentationmodel
  • Predicate Device Comparisonmodel