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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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      Assurance regarding legally compliant classification

      The European Medical Device Regulation (MDR) harmonizes requirements for medical devices across the EU and also governs the development and evaluation processes for system development and modification in the clinical sector.

      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 does the EU regulation cover?

      The MDR essentially addresses the following questions:

      • When is software classified as a medical device?
      • What roles are involved in the process?
      • What responsibilities must be fulfilled by each role?
      • How should the development be carried out and documented?

      What is INFORMATICS MDR?

      INFORMATICS MDR is software integrated into SAP i.s.h.med that significantly simplifies the process of MDR-compliant software development and classification. The mobile tool guides users through a questionnaire via its Fiori interface, ensuring data storage and consistent classification in accordance with EU legal requirements.

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

      • Assurance of compliance with the MDR classification requirements
      • Gradual expansion of customer development in compliance with legal requirements
      • Integrated Medical Device Registry (Inventory)
      • Transparency in classification and the resulting obligations
      • Full integration with SAP and the business unit's processes
      • Ongoing expansion of the explanatory notes on classifications

      The EU regulation applies to every clinical organization, regardless of the EHR system it uses. Here, our customers benefit from a significant simplification in meeting the resulting obligations.

       

      - Peter Altreiter, Managing Director INFORMATICS Healthcare

      Well-advised with INFORMATICS MDR

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      Expert advice from RnB Consulting, a specialist in legal matters related to medical software

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      Technical process support provided by INFORMATICS, an 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