AUDIT READINESS & REMEDIATION

The scheme, the auditor, the scope and the agenda determine the work. We start by reading your actual audit notice, not a generic checklist.

Notice first Scope drives the plan
Mock audit Before the real one
On site Closure at the factory
Evidence pack Assembled, not scrambled

THESE ARE NOT INTERCHANGEABLE

Each of these has a different scheme, a different auditor, and a different definition of adequate evidence. Preparing for one does not prepare you for another.

  • FDA inspection under the current compliance program
  • ISO 13485 certification or surveillance audit
  • MDSAP audit
  • UL medical-device GMP or process audit
  • Customer or private-label audit of you, or of your factory
  • Internal readiness assessment before you invite anyone

Where we work

Your side
Design file, risk and validation evidence, procedures against practice, and the records your team will be asked to produce
The factory's side
Executed production records, calibration, training, incoming inspection, and the corrective actions still open from last time
Between you
The quality agreement and the responsibility matrix, which is where a surprising number of findings originate

HOW THE ENGAGEMENT RUNS

  1. Read the notice

    Auditor, scheme, scope, product coverage, agenda, and any prior findings or open corrective actions. This determines everything downstream, and skipping it is how teams spend three weeks preparing the wrong material.

  2. Readiness matrix

    Each requirement in scope traced to the evidence that satisfies it, with the state of that evidence and the company that owns closing it. Gaps sorted by likelihood of examination and regulatory exposure, not by how easy they are to fix.

  3. Close what can be closed

    Real remediation rather than document cosmetics. Where the work is at the factory, our Shenzhen team leads it on site, in the language and time zone where it has to happen.

  4. Mock audit and interview preparation

    A rehearsal against the actual scope, including the part most teams neglect: preparing the people who will be in the room to answer precisely, from the record, without volunteering.

  5. Evidence package and request tracking

    A coherent package assembled in advance, and a live view of evidence requests during the audit so nothing is lost between the room and the factory.

  6. Response and CAPA follow-through

    Findings answered properly, corrective actions driven to closure, and effectiveness demonstrated before the next visit rather than the week before it.

Our role, and your auditor's. We prepare you for certification and regulatory bodies rather than acting as one. That separation is deliberate and it works in your favor: we can tell you exactly what we think a finding looks like, without any stake in the outcome of the audit itself.

If your evidence has never been mapped against the requirements that apply to your device, start with the fixed-scope diagnostic instead. It produces the readiness matrix in under two weeks, and audit preparation is then a much shorter conversation. Related reading: why a complete procedure index is not readiness.

AUDIT ON THE CALENDAR?

Send us the notice and the scope. We will tell you what the real exposure is and whether the timeline is achievable.

Book a discovery call See the diagnostic