| Name | Unterstützung | Language | Verfügbarkeit | Datum der Ausstellung | Preis | ||
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PDF |
Englisch |
gültig |
01.01.2016 |
268,00 € |
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Details
This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Annex 3
Zusätzliche Information
| Autor | Association for the Advancement of Medical Instrumentation (AAMI) |
|---|---|
| Veröffentlicht von | AAMI |
| Document type | Normen |
| Thema | Quality Systems/Regulatory Affairs |
| Datum der Bestätigung | 2019-01-01 |
| Schlagwort | ANSI/AAMI/ISO 13485:2016/(R)2019 |
