| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 31.03.2014 10:33:11 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.1.1 Software development plan |
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Overview- Organisation Chart
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- SOPs
- Templates
- Software tools
- Equipment
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- 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
- 5.1 Software development planning
- 5.1.1 Software development plan
5.1.1 Software development plan
«Functional» 5.1.1 Definition of the software development plan- «Functional» 5.1.1 a) Processes used in the development
- «Functional» 5.1.1 b) Deliverables of the activities and tasks
- «Functional» 5.1.1 c) Traceability between requirements, tests and risk control measures
- «Functional» 5.1.1 d) Software configuration and change management
- «Functional» 5.1.1 e) Software problem resolution for handling problems
- 5.1.2 Keep software development plan updated
- 5.1.3 Software development plan reference to system design and development
- 5.1.4 Software development standards, methods and tools planning
- 5.1.5 Software integration and integration testing planning
- 5.1.6 Software verification planning
- 5.1.7 Software risk management planning
- 5.1.8 Documentation planning
- 5.1.9 Software configuration management planning
- 5.1.10 Supporting items to be controlled
- 5.1.11 Software configuration item control before verification
- 5.2 Software requirement analysis
- 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