How to check your production documentation for audit readiness
Once production starts, it's too late for uncertainties in the documentation.
A missing test report, an unclear work instruction or an incomplete FMEA – and the audit or series release is already at risk.
To prevent exactly that from happening, we check your production documents before they go into manufacturing.
With our Production-Ready Report We ensure that your documentation is complete, traceable and audit-ready – according to EN ISO 13485 and with the perspective of experienced medical technology engineers.
Why is an independent review of the manufacturing documentation crucial?
Many projects show that gaps often arise between the completion of development and series production.
Interfaces between development, quality assurance and production quickly lead to missing or inconsistent documents – a risk for every audit.
Typical pitfalls in manufacturing documentation:
- Missing or inconsistent work instructions
- Incomprehensible version levels of specifications
- Unclear test criteria or missing test equipment definitions
- FMEAs without current process risks
- Manufacturing processes that are not fully validated
These weaknesses often only become apparent during the audit – when it becomes expensive and time-critical.
That's why we start earlier: We review your documents before production begins.
The MEDtech Production-Ready Report: Your audit check for manufacturing
In the Production-Ready Report Our experts analyze the documents necessary for smooth and compliant manufacturing.
From specifications and work instructions to FMEAs and validations, we check whether all content is complete, up-to-date, and comprehensible – with a focus on the requirements of the EN ISO 13485.
This is how the process works.
The Production Ready Report
Your current manufacturing documents will be encrypted and uploaded to our cloud.
This allows us to start a structured, efficient and secure analysis – from specifications and test instructions to validation documentation.
Our engineers check your documents for completeness, traceability and audit suitability.
In doing so, we identify gaps, inconsistencies, or risks that could jeopardize smooth production.
You will receive a detailed report with a clear assessment of your Production Readiness Level.
The report clearly shows where you are already audit-ready – and where there is room for improvement.
In a final discussion, we will explain the results, discuss specific recommendations for action, and, if desired, show you how to efficiently close the gaps.
If desired, we can also support you in the implementation – right up to the successful launch of production.
Your added value at a glance
Practical example: Series release without surprises
A customer was on the verge of receiving series production approval for his new medical device.
The internal audit revealed that several validation documents were missing and some work instructions did not comply with current specifications.
Within a few days, we reviewed all the documents, identified gaps, and provided recommendations for further documentation.
The result: Series production was approved without any issues – and the customer started production on time.
Get Production Ready Now
Do you want to know if your production documentation is truly audit-ready?
Then start with a free initial consultation with our manufacturing experts or view our entire service portfolio for Production & Manufacturing to.
Together we will bring your manufacturing To the point – audit-proof, efficient and ready for production.