IEC 62304 Know-how Set – Health Software
IEC 62304 Know-how Set – Health Software – Software Life Cycle Processes
IEC 62304 Know-how Set description
The IEC 62304 Know-how Set was prepared by practitioners in the SDLC domain. People in the following R&D roles ware engaged in its definition: Project Managers, Scrum Masters, Architects, Software Developers, Quality Assurance Engineers, UI/UX Designers and DevOpses. As a result, the know-how is explained in such a way that it can be integrated with Agile practices resulting in Agile/Maturity approach.
By buying the know-how set an Organization can develop health software up to Class C of software safety classification or Major Level of Concern(USA). Additionally, it will help your Software Development team in meeting requirements coming from ISO 27001 and Personal Data Privacy Regulations like e.g. GDPR.
The know-how set, in addition to the template content, also contains some empty elements which have to be prepared in the process of defining a Software Development Life Cycle. This stems from the fact that such content is organization-specific.
IEC 62304 Know-how Set statistics
Total
102
SDLC Roles
9
Information contexts
3
SDLC content
63
Education content
18
IEC 62304 Know-how Set elements
Organization (21)
Roles (9)
- Product Manager
- Business Analyst
- Configuration Manager/DevOps
- Developer
- Project Manager
- Quality Assurance (Tester)
- Solution Architect
- Technical Leader
- UI/UX Designer
Contexts (3)
- Quality Management
- Security
- Software Development
Normative sources (9)
- 9 regulations and standards, including:
- IEC 62304
- ISO 13485
- ISO 14971
- ISO 27001
Know-how (63)
Policies (1)
- Software Development Life Cycle Policy
Processes (15)
- Risk Management Process
- Architecture Design Process
- Business Analysis Process
- Change Management Process
- Configuration Management Process
- Detailed Design Process
- Documentation Management Process
- Implementation Process
- Infrastructure Management Process
- Project Management Process
- Release Management Process
- Software Maintenance Process
- Tests Design and Implementation Process
- Tests Execution Process
- UI/UX Design Process
Procedures (2)
- Product Release Procedure
- Software Development Life Cycle Procedure
Ins/Outs (45)
- Acceptance Criteria
- Analysis Outcomes
- Analysis Outcomes Review Record
- Baseline
- Binary Package
- Change
- Change Request
- Configuration Item
- Configuration Management Plan
- Detailed Design Outcomes
- Detailed Design Review Records
- Documentation Index
- Documentation Management Plan
- Environment Installation Manual
- Environment Installation Requirements
- Environment Specification
- External Interfaces
- Infrastructure Qualification Records
- Issues
- Operations Manual
- Problem Report
- Product Roadmap
- Project Operations Manual
- Release Deployment Manual
- Release Notes
- Release Package
- Requirements Review Record
- Software Development Plan
- Software Maintenance Plan
- Software Requirements
- Solution Architecture
- Solution Architecture Review Records
- Source Code
- Supplementary Project Plans
- Technology Stack Requirements
- Technology Stack Specification
- Test Case
- Test Item
- Test Plan
- Test Strategy
- Tests Execution Summary Report
- Tests Level Execution Report
- Tests Level Specification
- UI/UX Guidelines
- User Interface Design
Education (19)
Trainings (1)
- ins2outs User Training
Guidelines (1)
- Dictionary: Software Development
Tools (8)
- Configuration Management System (CMS)
- Continuous Integration System (CI)
- Definitive Media Library (DML)
- Documentation Management System (DMS)
- Issue Tracking System (ITS)
- Source Code Repository (SCR)
- Static Source Code Analysis (SSCA)
- Tests Management System (TMS)
Knowledge Bits (7)
- FDA – U.S. Food and Drug Administration
- Others …
Other services
IEC 62304 Training
IEC 62304 training is led by experienced software developers and project managers. First of all, within 12 hours of training you will be introduced to both Product Life Cycle (PLC) and Software Development Life Cycle (SDLC). Furthermore, you will be guided through all SDLC processes, software development project team roles and tools. Finally, the training is based on the IEC 62304 Know-how Set materials, you can buy them for your organization afterwards. All the participants receive an IEC 62304 training completion certificate required to prove competence and awareness.
IEC 62304 Consultancy
IEC 62304 consultancy is delivered by consultants from ins2outs ecosystem who specialize in SDLC and software engineering. As a result, you can bring the risk of developing health software down early in the software development life cycle. The consultant will customize the know-how set to the specific needs of your organization and conduct necessary training. Furthermore, they will help your organization to stay compliant supporting your team at agreed milestones. Finally, as an outcome of that service you will have internalized SDLC processes working in your organization.
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