Screenshots

Description

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

What’s New

Version 1.2.3

Improved calculations
Minor bugfixes

Information

Seller
Qserve Group BV
Size
47.3 MB
Category
Business
Compatibility
Requires iOS 8.2 or later. Compatible with iPhone, iPad, and iPod touch.
Languages
English
Age Rating
Rated 4+
Copyright
© 2016 - Qserve Group BV
Price
Free

Supports

  • Family Sharing

    With Family Sharing set up, up to six family members can use this app.

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