Certification Support.

As an initial key element for inclusion in the diGA directory according to the Digital Supply Act (DVG), there is no way to bypass certification as a medical device for digital health applications (diGA). QuR.digital has specialised in certification support for software-based applications with low-risk classes (I, IIa). From the creation of the intended purpose, through the creation of a technical documentation to the establishment of a quality management system according to ISO 13485, QuR.digital guides you through the certification process and provides you with all the necessary templates you need to set up a complete medical device documentation.

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