1. Medical Devices QMS
  2. Agent assistance
Reference

Put an AI agent to work in Medical Devices QMS

Use the agent entry point for this system:

Set it up

  1. Teach your agent ERP.AI

    Load the ERP.AI skill and paste the output into your agent. It explains how to read and update records in your workspace.

    curl -fsSL https://www.erp.ai/skill.md
  2. Give it a role

    Assign the agent its own user and one of the 6 roles. It gets exactly the access that role has, and no more.

  3. Check what it can reach

    Confirm which records, actions and connections the agent can use in your workspace before you point it at real data.

  4. Review its work and usage

    Check the drafts and changes it proposes, and watch its usage receipts as you give it more to do. Agent work uses prepaid credits.

What the agent can do

  • Inspector: Find planned inspections and the requirement checks that need observations.
  • Reviewer: Present a submitted inspection with its failed checks, certificate and device history links.
  • Action owner: List corrective actions by due date and show the linked nonconformance.
  • Document controller: Find a controlled revision and its linked acknowledgments.

What stays with a person

  • The responsible person decides inspection disposition, action approval and effectiveness.
  • The agent can assemble the record context and prepare a request, but the decision belongs to the named reviewer.
  • It should preserve the original requirement result and the link to the operational case.

The responsible person decides inspection disposition, action approval and effectiveness. The agent can assemble the record context and prepare a request, but the decision belongs to the named reviewer. It should preserve the original requirement result and the link to the operational case.

Set up Medical Devices QMS your way.

Start free, then use Proto to change fields, steps and approvals before your team goes live.

How to get started