Qserve EU MDR First Aid
Free
1.2.3for iPhone, iPad
Age Rating
Qserve EU MDR First Aid 螢幕截圖
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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最新版本1.2.3更新日誌
Last updated on 2017年05月12日
歷史版本
Improved calculations
Minor bugfixes
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Version History
1.2.3
2016年12月09日
Improved calculations
Minor bugfixes
Qserve EU MDR First Aid FAQ
點擊此處瞭解如何在受限國家或地區下載Qserve EU MDR First Aid。
以下為Qserve EU MDR First Aid的最低配置要求。
iPhone
iPad
Qserve EU MDR First Aid支持English