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Develop and Maintain Services
Primarily, the technical documentation serves as proof of compliance with regulatory requirements for market access; in Europe, that is compliance with the MDR general safety and performance requirements.
However, another aspect is just as important: The technical documentation is an important tool for minimizing risks of liability. Because only if you are able to reproduce properly whether an event on the market is due to a design error or may be limited to a batch, you may launch adequate and reasonably limited measures.
And there is yet another aspect about the technical documentation that is often underestimated in our opinion: If the development of the documentation is well interlinked with the product development process, the safety and predictability of the development process benefit tremendously.
