| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 31.03.2014 12:42:37 |
| Modified: | 01.01.2015 21:33:37 |
| Diagram Elements : |
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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
- 5.3 Software architectural design
- 5.4 Software detailed design
- 5.5 * SOFTWARE UNIT implementation and verification
- 5.5 * SOFTWARE UNIT implementation and verification
- 5.5.1 Implement each SOFTWARE UNIT
- 5.5.2 Establish SOFTWARE UNIT VERIFICATION PROCESS
- 5.5.3 SOFTWARE UNIT acceptance criteria
- 5.5.4 Additional SOFTWARE UNIT acceptance criteria
5.5.4 Additional SOFTWARE UNIT acceptance criteria
«Functional» 5.5.4 a) Proper event sequence- «Functional» 5.5.4 b) Data and control flow
- «Functional» 5.5.4 c) Planned ressource allocation
- «Functional» 5.5.4 d) Fault handling (error definition, isolation, and recovery)
- «Functional» 5.5.4 e) Initialisation of variables
- «Functional» 5.5.4 f) Self-diagnostics
- «Functional» 5.5.4 g) Memory management and memory overflows
- «Functional» 5.5.4 h) Boundary conditions
- 5.5.5 SOFTWARE UNIT 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