Your path to class I.
In order to ensure the marketability of health applications and other digital medicine products within the EU in the future, licensing as a medical device has become practically inevitable. Through close cooperation with the Bundesverband für Internetmedizin (BiM) and the responsible supervisory authorities, QuR.digital has already been able to gain extensive experience in this area, from which you can now benefit. Together with our partners, QuR.digital guides you safely and purposefully through the process of self-certification under class I.
Step 1: Product analysis
Products without systemic risks, which do not provide information for diagnosis or therapy, are generally assigned to risk class I. This classification is based on the regulations of the medical device law and thus in future particular the Medical Device Regulation (MDR). We analyze your product and show you possibilities how to position your product in the best possible way within legal framework.
Step 2: Certification support
On the basis of the completed product analysis, QuR.digital accompanies you through the entire process of self-certification, from creating the intended purpose to registering your product with the DIMDI. Together with our partners, QuR.digital supports the certification process so comprehensively that the result is a sustainable marketability as a class I medical device.
Step 3: BiM-Seal
In cooperation with and on behalf of the Bundesverband für Internetmedizin (BiM), QuR.digital also offers you the opportunity to certify yourself under the seal "Quality Product Internet-Medicine" issued by BiM. Set yourself apart from your competitors and demonstrate a particularly high quality standard by meeting additional requirements for the quality and safety of your product.