| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 31.03.2014 12:26:35 |
| Modified: | 01.01.2015 21:03:31 |
| 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
- 5.3 Software architectural design
- 5.3.1 Transform software requirements into an architecture
- 5.3.2 Develop an architecture for the interfaces of software items
- 5.3.3 Specify functional and performance requirements of SOUP item
- 5.3.4 Specify SYSTEM hardware and software required by SOUP item
- 5.3.5 Identify segregation necessary for RISK CONTROL
- 5.3.6 Verify software ARCHITECTURE
5.3.6 Verify software ARCHITECTURE
«Functional» 5.3.6 a) Architecture implements system and software requirements including those relating to risk control- «Functional» 5.3.6 b) Architecture is able to support interfaces software items and hardware
- «Functional» 5.3.6 c) Medical device architecture supports proper operation of any SOUP items
- 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