速報APP / 商業 / Qserve EU MDR First Aid

Qserve EU MDR First Aid

價格:免費

更新日期:2017-05-12

檔案大小:47.3 MB

目前版本:1.2.3

版本需求:需要 iOS 8.2 或以上版本。與 iPhone、iPad 及 iPod touch 相容。

支援語言:英語

Qserve EU MDR First Aid(圖1)-速報App

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.

Qserve EU MDR First Aid(圖2)-速報App

Key changes covered

• Scope & Classification

• Notified Bodies

• Conformity Assessment

Qserve EU MDR First Aid(圖3)-速報App

• Supply Chain Control

• Safety and Performance Requirements

• Clinical Data & Equivalence

• PMS & PMCF

Qserve EU MDR First Aid(圖4)-速報App

• Traceability & Registration

• Liability

Qserve EU MDR First Aid(圖5)-速報App

支援平台:iPhone, iPad