Development and maintenance of your technical documentation
Your technical documentation should be synchronized with product development or even better, be one step ahead of each development stage! Because it may only then be ensured that the medical device meets all regulatory requirements and will be approved without any expensive delays. It should by no means be developed ex post: As the documents are interrelated, a historical order is created.
The product file must be updated continuously according to the findings of market observation throughout the entire life cycle. In addition, the effects of changes to the product, e.g. due to a discontinued component, or due to changed manufacturing processes, must also be documented accordingly.
If you integrate our services into your development process at an early stage, the technical documentation will efficiently support the quick and safe development of your medical device!
Our services in this field
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"Once basic documentation is available, preparation of the application documents for the target country is rather easily manageable."