CE Accreditation and Barriers to CE Marking of Pediatric Drug Calculators for Mobile Devices: Scoping Review and Qualitative Analysis
BackgroundPediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown. Objecti...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2021-12-01
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| Series: | Journal of Medical Internet Research |
| Online Access: | https://www.jmir.org/2021/12/e31333 |