IEC 62304 Know-how Set – Health Software

IEC 62304 Know-how Set – Health Software – Software Life Cycle Processes

IEC 62304 know-how set – Health software - Software Life Cycle Processes

IEC 62304 Know-how Set description

This know-how set is based on new IEC/DIS 62304 Health Software – Software Life Cycle Processes standard. It defines a Software Development Life Cycle (SDLC) process which should be followed when developing software for a medical device or health systems. Therefore, the know-how set includes SDLC team roles definitions, explains the processes used, and bases them strongly on modern software development tools. In addition to that, you will find here a set of document templates required as deliverables from IEC 62304 compliant SDLC process.

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



SDLC Roles


Information contexts


SDLC content


Education content


IEC 62304 Know-how Set elements

Organization (21)

Roles (9)
  1. Product Manager
  2. Business Analyst
  3. Configuration Manager/DevOps
  4. Developer
  5. Project Manager
  6. Quality Assurance (Tester)
  7. Solution Architect
  8. Technical Leader
  9. UI/UX Designer
Contexts (3)
  1. Quality Management
  2. Security
  3. Software Development
Normative sources (9)
  1. 9 regulations and standards, including:
  2. IEC 62304
  3. ISO 13485
  4. ISO 14971
  5. ISO 27001

Know-how (63)

Policies (1)
  1. Software Development Life Cycle Policy
Processes (15)
  1. Risk Management Process
  2. Architecture Design Process
  3. Business Analysis Process
  4. Change Management Process
  5. Configuration Management Process
  6. Detailed Design Process
  7. Documentation Management Process
  8. Implementation Process
  9. Infrastructure Management Process
  10. Project Management Process
  11. Release Management Process
  12. Software Maintenance Process
  13. Tests Design and Implementation Process
  14. Tests Execution Process
  15. UI/UX Design Process
Procedures (2)
  1. Product Release Procedure
  2. Software Development Life Cycle Procedure
Ins/Outs (45)
  1. Acceptance Criteria
  2. Analysis Outcomes
  3. Analysis Outcomes Review Record
  4. Baseline
  5. Binary Package
  6. Change
  7. Change Request
  8. Configuration Item
  9. Configuration Management Plan
  10. Detailed Design Outcomes
  11. Detailed Design Review Records
  12. Documentation Index
  13. Documentation Management Plan
  14. Environment Installation Manual
  15. Environment Installation Requirements
  16. Environment Specification
  17. External Interfaces
  18. Infrastructure Qualification Records
  19. Issues
  20. Operations Manual
  21. Problem Report
  22. Product Roadmap
  23. Project Operations Manual
  24. Release Deployment Manual
  25. Release Notes
  26. Release Package
  27. Requirements Review Record
  28. Software Development Plan
  29. Software Maintenance Plan
  30. Software Requirements
  31. Solution Architecture
  32. Solution Architecture Review Records
  33. Source Code
  34. Supplementary Project Plans
  35. Technology Stack Requirements
  36. Technology Stack Specification
  37. Test Case
  38. Test Item
  39. Test Plan
  40. Test Strategy
  41. Tests Execution Summary Report
  42. Tests Level Execution Report
  43. Tests Level Specification
  44. UI/UX Guidelines
  45. User Interface Design

Education (19)

Trainings (1)
  1. ins2outs User Training
Guidelines (1)
  1. Dictionary: Software Development
Tools (8)
  1. Configuration Management System (CMS)
  2. Continuous Integration System (CI)
  3. Definitive Media Library (DML)
  4. Documentation Management System (DMS)
  5. Issue Tracking System (ITS)
  6. Source Code Repository (SCR)
  7. Static Source Code Analysis (SSCA)
  8. Tests Management System (TMS)
Knowledge Bits (7)
  1. FDA – U.S. Food and Drug Administration
  2. Others …

Other services

In addition to the know-how set we offer complementary service on IEC 62304 such as:


  • 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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