Non-conformity response: start by finding out whether the evidence already exists.
Evidence search across your documentation, root cause analysis, CAPA plan and drafting of the responses to your Notified Body, with one round of exchanges included.
Initial scoping is free, with no commitment. Fixed-price service, per batch of non-conformities.
What you get
- Root cause analysis
- CAPA plan
- Drafting of the responses
- One exchange cycle with the Notified Body
Good to know
- Per batch of non-conformities
Ideal if: you have just received a non-conformity report and the deadline to answer the Notified Body is short.
Two situations, two very different responses
A finding raised in an audit does not always mean something is missing. It means the demonstration was not made in the time allowed. That is not the same thing, and confusing the two costs weeks.
The evidence exists but was not found
An audit runs under time pressure. The auditor asks, the team searches, cannot find it in the minutes available, and the finding is recorded. Yet the document existed, elsewhere in the system, under another name or in another folder. There is then nothing to correct: there is something to demonstrate.
The evidence does not exist
Here the gap is real. You need to understand why it occurred, produce what is missing, check whether the same cause has produced other gaps elsewhere, and demonstrate all of this. It is in-depth work that speed cannot replace.
What the platform does with a non-conformity report
You load the Notified Body's report into My Audit Corner. It is read and cross-checked against your entire document base in a few minutes.
In the first case, the platform surfaces the evidence that neither your teams nor the auditor found on the day of the audit, and drafts the corresponding response. What used to take days of document searching becomes immediate, and speed is entirely legitimate here since there is nothing to correct.
In the second case, it describes what is missing, what needs to be produced and how. You create the expected document, feed it into the platform, and it drafts the response based on that new evidence.
In both cases, it assists with the regulatory writing: wording of the cause, impact analysis, corrective actions. This is the heaviest and most codified part of the work, and the one that most often holds up the closure of a non-conformity.
Responsibility for the response remains yours, and our experts validate it before it is sent. What the platform removes is the searching time and the blank page, not regulatory judgement.
Correction, corrective action, extension: three distinct things
When the gap is real, a Notified Body expects more than a correction of the reported case. A response that corrects without analysing is spotted immediately: it is sent back, the clock restarts, and the credibility of your system is damaged just when it matters most.
The correction addresses the reported case
The missing document is written, the record is completed. Necessary, never sufficient.
The corrective action addresses the cause
Why was the document missing? An undefined process, missing training, a workload that causes a step to be skipped. This is where the acceptance of your response is decided.
The extension looks elsewhere
If the cause produced this gap here, it has probably produced others in files the auditor did not examine. The platform runs this search across your entire document base, so you can respond with verified facts rather than a statement of principle.
Frequently asked questions
It produces the drafted response, and that is precisely its value on the codified part of the work: wording of the cause, impact analysis, corrective actions. Responsibility for what is sent remains yours, and our experts validate every response before submission. A document addressed to a Notified Body commits the manufacturer, not a piece of software.
Because some of the findings raised in audits do not reflect anything actually missing: the evidence existed but was not found within the time of the interview. The platform searches your entire document base, without the time pressure of the audit, and surfaces the evidence. The response is then immediate because there is nothing to correct.
It varies by Notified Body and severity, generally from a few weeks to three months for a major non-conformity. The deadline is stated in the report and is rarely negotiable. That constraint is what shapes the service.
Yes. The approach is the same, whether it is an ISO 13485 certification body or a Notified Body under the MDR or IVDR. Only the standard and the expected formalities change.
One round of exchanges with the Notified Body is included in the service, which covers the usual case of a request for clarification. If the rejection reveals an underlying issue broader than the initial scope, we tell you and scope the next steps separately rather than rushing what cannot be rushed.
Yes, and it is the first input to scoping. The exact wording of the findings, their grading and the requirements cited determine the whole response strategy. It is also the document the platform reads to start searching your document base.
Just received a non-conformity report?
Send us the report and the response deadline. Scoping is free, and it is quick.