Qserve EU MDR First Aid
Free
1.2.3for iPhone, iPad
Age Rating
لقطات الشاشة لـ Qserve EU MDR First Aid
About Qserve EU MDR First Aid
A 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.
Deliverables
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
• PMS & PMCF
• Traceability & Registration
• Liability
Deliverables
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
• PMS & PMCF
• Traceability & Registration
• Liability
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تحديث لأحدث إصدار 1.2.3
Last updated on 12/05/2017
الإصدارات القديمة
Improved calculations
Minor bugfixes
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Version History
1.2.3
08/12/2016
Improved calculations
Minor bugfixes
Qserve EU MDR First Aid FAQ
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iPhone
iPad
Qserve EU MDR First Aid هي مدعومة على اللغات English