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Medical Device Regulation

The fully integrated SAP i.s.h.med add-on from INFORMATICS simplifies MDR-compliant software development and classification.

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      Security with regard to legally compliant classification

      The European Medical Device Regulation (MDR) standardises the requirements for medical devices throughout the EU and also controls the development and assessment processes of system development/modification in the clinical area.

      In order to be able to map these requirements uniformly and to support stakeholders in the assessment, our SAP-i.s.h.med colleagues from the field have developed the Medical Device Regulation tool together with Cerner and RnBconsulting, which accompanies the development process - starting with the initial assessment through to re-evaluation in the event of a change.

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      What is regulated in the EU Regulation?

      The MDR basically deals with the following questions:

      • When is software classified as a medical device
      • What roles exist in the process involved
      • What duties must be fulfilled by the individual roles
      • How must the development be carried out and documented

      What is INFORMATICS MDR?

      INFORMATICS MDR is a software integrated in SAP i.s.h.med that significantly simplifies the process of MDR-compliant software development and classification. The mobile tool guides the user through a questionnaire via its Fiori interface, which ensures data storage and uniform classification based on EU legal principles.

      Achieve certainty with regard to legally compliant classification in accordance with MDR - these and other benefits

      • Safety with regard to legally compliant classification according to MDR
      • Successive expansion of legally compliant customer developments
      • Integrated Medical Devices Inventory (Inventory)
      • Transparency in classification and the resulting obligations
      • Complete integration into SAP and the processes of the specialist department
      • Ongoing expansion of the explanations on the classifications

      The EU regulation affects every clinical company, regardless of the HIS system used. Here, our customers benefit from a strong simplification in the fulfilment of the resulting obligations.

       

      - Peter Altreiter, Managing Director INFORMATICS Healthcare

      Well advised with INFORMATICS MDR

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      Expert advice by RnB Consulting, specialist for legal issues in the field of medical software

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      Technical process support by INFORMATICS, SAP Gold Partner and expert in SAP i.s.h.med.

      Do you have any questions? Then write to us!

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      Contact

      Bettina Hetzmannseder
      Head of Product Management