| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 31.03.2014 12:08:03 |
| Modified: | 30.12.2014 15:41:08 |
| Diagram Elements : |
|
|
|
|
|
EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- 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 62304 Software
- 3 Terms and definitions
- 4 General requirements
- 5 Software development process
- 5 Software development process
- 5.1 Software development planning
- 5.2 Software requirement analysis
- 5.2 Software requirement analysis
- 5.2.1 Define and document software requirements from system requirements
- 5.2.2 Software requirements content
- 5.2.3 Include risk control measures in software requirements
- 5.2.4 Re-evaluate medical device risk analysis
- 5.2.5 Update system requirements
- 5.2.6 Verify software requirements
- 5.3 Software architectural design
- 5.4 Software detailed design
- 5.5 * SOFTWARE UNIT implementation and verification
- 5.6 * Software integration and integration testing
- 5.7 Software system testing
- 5.8 * Software release
- 6 Software maintenance process
- 7 * Software RISK MANAGEMENT PROCESS
- 8 Software configuration management process
- 9 * Software problem resolution PROCESS
- 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