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VALIDATION CREATES CONFIDENCE

Although generally considered to be of the highest importance,
validation nevertheless does not always get the attention it deserves.

At Scholz, we don’t see validation as a necessary evil, but rather as an
essential cornerstone for medical devices of the highest quality. Therefore,
right from the quotation stage we set out the specific needs and requirements
of a validation with our customers. 

Confidence creates reliability

We can offer various modules, such as statistical quality control (SPC), statistical design of
experiments (DoE)
or Validation by way of DQ/IQ/OQ/PQ in accordance with the specifications
of the FDA
– in each case accompanied by comprehensive documentation.

In addition, thanks to our technical infrastructure we can monitor and electronically document
all quality-related process parameters in-line. It goes without saying that our manufacturing
facilities are validated according to the specifications of ISO 13485 and reflect the guidelines of
the IMDRF (formerly GHTF) and FDA, and undergo preventive maintenance. 

Safety for your product

We work together with renowned, accredited laboratories for biological testing to ISO 10993,
as well as the evaluation of the bioburden by quantifying the colony-forming units (CFU). 

If your product requires it, we can also validate and support all of our additional services
with risk management. Validation is the best way to create extra confidence in the quality of our
processes and services. 

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