| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Paul Glaeser |
| Status: | Proposed |
| Created: | 26.07.2017 12:46:09 |
| Modified: | 30.08.2017 22:31:27 |
| Advanced : | |
| Appears In: | Compliance |
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EA Project Browser
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Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- CFR 820 Code of Federal Regulations Title 21
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- Sandbox