價格：免費
更新日期：2017-05-11
檔案大小：17M
目前版本：1.2.22
版本需求：Android 4.1 以上版本
官方網站：http://www.qservegroup.com
Email：marketing@qservegroup.com
聯絡地址：隱私權政策
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
