| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 01.04.2014 13:52:54 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.6 USABILITY VALIDATION plan |
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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 62366 Usability
- IEC 62366 Usability
- 3 Terms and definitions
- 4 Principles
- 5 USABILITY ENGINEERING PROCESS
- 5 USABILITY ENGINEERING PROCESS
- 5.1 Application specification
- 5.2 Frequently used functions
- 5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS
- 5.4 PRIMARY OPERATING FUNCTIONS
- 5.5 USABILITY SPECIFICATION
- 5.6 USABILITY VALIDATION plan
5.6 USABILITY VALIDATION plan
«Functional» 5.6 Specify method used for VALIDATION of the USABILITY of the PRIMARY OPERATING FUNCTIONS- «Functional» 5.6 Specify criteria for determining succesfull VALIDATION of the USABILITY of the PRIMARY OPERATING FUNCTIONS
- «Functional» 5.6 Specify the involvement of representative intended USERS
- «Functional» 5.6 USABILITY VALIDATION methods and performing environment
- «Functional» 5.6 Address frequent USE SCENARIOS
- «Functional» 5.6 Address reasonable foreseeable worst case USE SCENARIOS
- 5.7 USER INTERFACE design and implementation
- 5.8 USABILITY VERIFICATION
- 5.9 USABILITY VALIDATION
- 6 ACCOMPANYING DOCUMENT
- 7 Training and materials for training
- 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