Estimation application downloads and cost
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
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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
ASO analyse Qserve EU MDR First Aid app for iPhone and iPad
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Competitors of Qserve EU MDR First Aid application
Application availability
Available in countries
Country | Price |
---|---|
Canada | free |
China | free |
France | free |
Germany | free |
Italy | free |
Netherlands | free |
Portugal | free |
Spain | free |
Poland | free |
UK | free |
India | free |
Japan | free |
Poland | free |
Russia | free |
Turkey | free |
USA | free |
Korea, Republic Of | free |
Ukraine | free |