Critical Onsite Response

Boots-on-the-ground response for critical customer issues: contain the impact, fix the root cause, preserve the evidence, and document for QA before you leave the building.

Overview

When a regulated MedTech product fails on a clinical floor, three things have to happen in parallel: clinical operations have to keep moving, the technical root cause has to be found, and every action has to be recorded for QA and potential regulator review. Remote support cannot do all three at once.

Critical onsite response puts a trained engineer at the customer's location within 24 hours of a P1 trigger. They carry containment authority, the runbook, and a Part 11-compliant evidence kit. By the time they leave, the floor is operational, the root cause is documented, and the evidence is in your QMS.

Our Process

  1. 1

    Trigger & dispatch

    Defined P1 criteria automatically dispatch the nearest qualified engineer. Average arrival: 24 hours from page.

  2. 2

    Containment

    First priority on arrival: restore clinical operations, even if via documented workaround. The runbook governs every step.

  3. 3

    Root cause investigation

    Logs preserved with hashes, hardware photographed, workflow recreated with site staff.

  4. 4

    Resolution

    Fix applied per change control. Customer-facing engineer holds the room until the fix is verified live.

  5. 5

    Documentation & handoff

    Full incident record signed off onsite. CAPA opened if criteria are met. MDR triage notes flagged for QA.

Frequently Asked Questions

What qualifies as a P1 trigger?

We agree on criteria upfront: typically patient impact, total deployment outage, or any event likely to be reportable. The criteria sit in the contract.

Do you cover international sites?

Continental US is base coverage. International coverage is available via partner network with longer arrival SLAs.

Who keeps the evidence?

You do. We capture in your tooling using your accounts. We hold nothing outside your control.

Can you train our internal team to do this?

Yes, many engagements start with us co-responding, then transition to your team owning P1 with us on call.

When the floor is down, ours is the team that arrives.

Share your last P1 incident and your current response capability. We will return a coverage proposal scoped to your deployed footprint.

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