| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 31.03.2014 10:14:18 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 4.3 Software-Sicherheitsklassifizierung |
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Overview- Organisation Chart
- Staff
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- SOPs
- Templates
- 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
- 4 General requirements
- 4.1 Quality management system
- 4.2 Risk management
- 4.3 Software safety classification
4.3 Software-Sicherheitsklassifizierung
«Functional» 4.3 a) Assignment to software safety classifications (A,B or C) for each software system- «Functional» 4.3 b) Assignment of software safety class for each software-system contribution to risk mitigation
- «Functional» 4.3 c) Document software safety classification in risk management file
- «Functional» 4.3 d) Segragation of software and separate classifications
- «Functional» 4.3 e) Decumentation of software items in case of separate risk calssifications
- «Functional» 4.3 f) Application of required processes for highest-classified software item
- «Functional» 4.3 g) Class C software safety classification as default
- 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