1. Medical Devices QMS
  2. Get started
Get started

Get Medical Devices QMS running in four steps.

Begin with a representative inspection and rehearse its evidence and reviewer handoffs.

  1. Create your account

    Click Start now and create your ERP.AI account.

    Start now
  2. Download Proto

    Proto is the desktop app you use to set up Medical Devices QMS. It runs on macOS, Windows and Linux.

    Download Proto
  3. Make it yours

    Open Medical Devices QMS in Proto and adjust fields, steps, roles and approvals to match how your team works.

    Implementation plan
  4. Bring your data and team

    Import your records, then invite your team and assign their roles.

    See the roles

Create your account

Click Get started and use Proto to configure QMS for Medical Devices for your team. Identify the Inspector, Quality Reviewer and Corrective Action Owner who will run the first case.

Prepare the first operating cycle

Choose an incoming or final inspection with a subject reference your team recognizes. Prepare its requirements, a passing and a failing example, and the evidence attachments the reviewer will need. If the case involves a supplier certificate or device history package, prepare the matching file and identifier.

Review before release

Have the Inspector submit the case and the Quality Reviewer decide the disposition. Follow a failed check into a nonconformance and corrective action, then rehearse effectiveness review. Confirm that the same inspection and its evidence remain easy to find. See implementation for the rollout path.

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