The medical technology is concerned with the development and production of simple consumer products, complex medical equipment, complete systems for prevention, diagnostics and therapeutics.
Validation/qualification of such systems is regulated by national and international guidelines and/or laws. Due to the high demands regarding quality, security and traceability, a completely documented proof of the product design, the development process as well as the fulfillment of the specified (product) quality criteria, has to be established.
The validation is the documented evidence that the procedure or the process of a device leads to the anticipated result.
With the qualification of a system the written proof documents that the system was planned, ordered, installed in accordance to the requirements, and that it corresponds to the user’s requirements leading to the expected results.The product must fulfill the defined specification.
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