Assessments
Full Audit Readiness Assessment
A document review tells you what your procedures say. A readiness assessment tells you whether your records, evidence and people back them up, measured against the audit you actually have coming. You get a readiness view by area and a reviewed plan for closing what's open.
What You Receive
- 01Readiness View by Area
- 02Records and Evidence Findings
- 03Interview Observations
- 04Prioritized Action Plan
Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.
What It Is
Auditors and investigators don't stop at procedures. They pull records, follow a complaint into a CAPA, ask a process owner to walk through how a change was approved, and look for evidence that the system runs the way it's written. A full readiness assessment does the same, before they do.
We build the assessment around a specific audit. For an FDA inspection, that means the six QMS areas and four other FDA requirements in Compliance Program 7382.850, starting from your risk management documentation. For ISO 13485, it means what a certification body examines at Stage 1 (documentation and readiness) and Stage 2 (implementation), or at surveillance and recertification. For an MDSAP audit, where one audit by a recognized auditing organization covers the requirements of the participating regulators, the scope widens to those regulators' requirements. Notified body and customer audits follow their own scope.
The output is a readiness view by area: where you're in good shape, where records or evidence are thin, and where a process owner's answer would raise more questions than it settles. Every finding is advisor-reviewed and lands in the same action plan your team works from on the platform.
When You Need It
- An ISO 13485 Stage 1, Stage 2, surveillance or recertification audit is on the calendar.
- You're entering MDSAP and want to see how your system holds up across the participating regulators' requirements.
- A notified body conformity assessment or surveillance audit is coming under EU MDR or IVDR.
- A major customer has scheduled an audit of your facility as one of its suppliers.
- You haven't had an FDA inspection under QMSR yet and want to know where an investigator would focus.
- Your last audit produced findings and you want independent confirmation that the fixes are working.
What We Do
- 01
Define the Target Audit
We identify the audit, the auditing body, the scope of certification or inspection and any prior findings, then set the readiness areas to match.
- 02
Review Documents and Sample Records
The AI-assisted first pass maps your procedures to the requirements. The advisor then samples records across complaints, CAPA, nonconformances, design changes, supplier controls and training to test whether the procedures are followed.
- 03
Trace Evidence Across Processes
We follow threads the way an auditor would, such as a complaint through investigation, reporting decision and CAPA, or a supplier issue back through purchasing controls, to find where the chain breaks.
- 04
Interview Process Owners
Short interviews with the people most likely to face the auditor show whether they can explain their process, find their records and stay within what they know.
- 05
Deliver the Readiness View and Plan
We rate readiness by area, agree priorities with you and load every reviewed finding into the action plan with owners, due dates and evidence requirements.
Deliverables
Readiness View by Area
A clear status for each area in scope, organized around the structure of the audit you're facing.
Records and Evidence Findings
Advisor-reviewed findings from records sampling and evidence tracing, each tied to the record or document behind it.
Interview Observations
Notes on where process owners answered clearly and where they need coaching before the audit.
Prioritized Action Plan
Every open item with an owner, due date and a 'what to submit' checklist, sorted by severity.
How the Platform Helps
One Audit Readiness Workspace
Documents, findings, evidence and comments sit in one place, so nobody has to chase status through email threads.
Evidence Accepted or Returned
Owners submit evidence against each action. The advisor accepts it or requests a revision with a note, and resubmissions state what changed.
Notifications and Activity History
Comments and notifications keep owners moving, and an immutable activity history records every action taken.
Audits and Inspections It Prepares You For
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
ISO 13485 Certification Audit (Stage 1 and Stage 2)
The Stage 1 and Stage 2 audits a certification body runs before granting ISO 13485 certification.
ISO 13485 Surveillance Audit
The periodic audits, at least annually, that support continued ISO 13485 certification between renewals.
MDSAP Audit
One audit by a recognized auditing organization that covers several participating regulators, including FDA.
EU Notified Body Audit (Including Unannounced Audits)
Conformity assessment, surveillance and unannounced audits by an EU notified body under the MDR or IVDR.
Customer Audit
A customer's audit of your quality system, often a device maker auditing a supplier or contract manufacturer.
FDA Non-Baseline Surveillance Inspection
A focused FDA surveillance inspection that goes deep on selected QMS areas under Compliance Program 7382.850.
ISO 13485 Recertification Audit
The pre-expiry audit that reviews the whole ISO 13485 system and how it performed over the three-year cycle.
Internal Audit
Audits your own team runs of your quality system, now open to FDA inspection under the QMSR.
Remote and Hybrid Audits
Audits and regulatory assessments run partly or fully through video, screen sharing and electronic records.
Standards and Regulations in Scope
Questions About This Service
How is this different from the AI-assisted gap assessment?
The gap assessment focuses on whether your documented system covers the requirements. This assessment goes further: it samples records, traces evidence across processes and interviews process owners, all aimed at a specific audit. It's the better fit when an audit is scheduled or your documents are already in reasonable shape.
Which audits can you prepare us for?
FDA inspections, ISO 13485 certification, surveillance and recertification audits, MDSAP audits, EU notified body audits under MDR or IVDR, and customer audits. The readiness areas change with the audit, so we set scope around the one you're facing.
Do you interview our staff?
Yes, with your agreement. We speak with the process owners most likely to be questioned, to see whether they can explain their process and locate their records. The purpose is preparation, not evaluation of individuals.
Does a strong readiness result mean we'll get our certificate?
No. Certification decisions belong to the certification body, and inspection outcomes to FDA. A readiness assessment shows you where the risk sits and gives you a reviewed plan to address it before the audit.
How is it priced?
Engagements are scoped after an assessment call. The audit type, number of sites and depth of records sampling all affect the work.
Request an Assessment
Discuss Full Audit Readiness Assessment With an Advisor
Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.
