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Qserve EU MDR First Aid

Qserve EU MDR First Aid

Qserve Group BV

1.2.3 for iPhone, iPad
Free
0

0 Ratings

Update Date

2017-05-12

Size

45.1 MB

Screenshots for iPhone

More Screenshots for iPad
Qserve EU MDR First Aid 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
Qserve EU MDR First Aid 1.2.3 Update
2017-05-12 Version History
Improved calculations
Minor bugfixes
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More Information
Price:
Free
Version:
1.2.3
Size:
45.1 MB
Update Date:
2017-05-12
Developer:
Qserve Group BV
Language:
English
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