| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 03.04.2014 16:13:35 |
| Modified: | 30.12.2014 00:08:00 |
| 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
3 Terms and definitions
3.1 ACTIVITY- 3.2 ANOMALY
- 3.3 ARCHITECTURE
- 3.4 CHANGE REQUEST
- 3.5 CONFIGURATION ITEM
- 3.6 DELIVERABLE
- 3.7 EVALUATION
- 3.8 HARM
- 3.9 HAZARD
- 3.10 MANUFACTURER
- 3.11 MEDICAL DEVICE
- 3.12 MEDICAL DEVICE SOFTWARE
- 3.13 PROBLEM REPORT
- 3.14 PROCESS
- 3.15 REGRESSION TESTING
- 3.16 RISK
- 3.17 RISIK ANALYSIS
- 3.18 RISIK CONTROL
- 3.19 RISK MANAGEMENT
- 3.20 RISK MANAGEMENT FILE
- 3.21 SAFETY
- 3.22 SECURITY
- 3.23 SERIOUS INJURY
- 3.24 SOFTWARE DEVELOPMENT LIFE CYCLE MODEL
- 3.25 SOTWARE ITEM
- 3.26 SOFTWARE PRODUCT
- 3.27 SOFTWARE SYSTEM
- 3.28 SOFTWARE UNIT
- 3.29 SOUP
- 3.30 SYSTEM
- 3.31 TASK
- 3.32 TRACEABILITY
- 3.33 VERIFICATION
- 3.34 VERSION
- 4 General requirements
- 5 Software development process
- 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