EU MDR First Aid - Sluneč

 EU MDR First Aid 1.1.0

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Aplikace pro: iPhone, iPad


An interesting tool for medical device manufacturers involved in the European regulations with a questionnaire based on the key changes in the new European Medical Device Regulations (MDR). The outcome of the questionnaire gives basic insight in your position, marked as a (part of) 100%, on the road to EU-MDR compliance and that of the other medical device manufacturers using this application.

Nine sections are covered, and include relevant questions per section. A simple yes or no will lead you through the whole questionnaire. Finally, a graphic per subject will be displayed, with a 100
% score reflecting control of changes, and N/A score not influencing your current status. In case the subject is applicable and you did not score the maximum 100%, a few suggestions are given about where to focus and how to act to master this change.

Key changes covered
• Scope & Classification
• Notified Bodies
• Conformity Assessment
• Supply Chain Control
• Safety and Performance Requirements
• Clinical Data & Equivalence
• Traceability & Registration
• Liability
  • Verze programu


  • Poslední aktualizace od vývojáře

    5. 4. 2017 2017-04-05

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  • Velikost

    45,61 MB 45.61 MB

  • Web autora

  • Obchod
  • Systémové požadavky

    Aplikace pro: iPhone, iPad

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