| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 06.08.2014 15:38:01 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | Council directive 93/42/EEC, Annex II |
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EA Project Browser
Overview- Organisation Chart
- Staff
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- SOPs
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
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
- Council directive 93/42/EEC, Annex II
- 1. Application of quality system
- 2. CE declaration of conformity
- 3. Quality system
- 4. Examination of the design of the product
- 5. Surveillance
- 6. Administrative provisions
- 7. Application to devices in Classes IIa and IIb
- 8. Application to the devices referred to Article 1 (4a)
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- Sandbox