| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 31.03.2014 12:00:32 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.2.2 Software requirement content |
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Overview- Organisation Chart
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- SOPs
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- Software tools
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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
- 5.2 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
5.2.2 Software requirement content
«Functional» 5.2.2 a) Functional and capability requirements- «Functional» 5.2.2 b) Ein- und Ausgaben des Systems
- «Functional» 5.2.2 c) Interfaces between the software system and other systems
- «Functional» 5.2.2 d) Software-driven alarms, warnings and operator messages
- «Functional» 5.2.2 e) Security requirements
- «Functional» 5.2.2 f) Usability engineering requirements
- «Functional» 5.2.2 g) Data definition and database requirements
- «Functional» 5.2.2 h) Installation and acceptance requirements at the operation and maintenance site
- «Functional» 5.2.2 i) Requirements related to methods of operation and maintenance
- «Functional» 5.2.2 j) User documentation to be developed
- «Functional» 5.2.2 k) Maintenance requirements
- «Functional» 5.2.2 l) Requlatory requirements
- 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