Software quality policy is defined according to EN 62304/ISO 90003. The Software Development Life Cycle (SDLC) Procedure includes the following topics:

1. software requirements
2. software design
3. software/feature implementation
4. software reviews
5. software releases
6. software testing
7. software configuration management
8. software quality assurance
9. off the shelf software validation

The following issues are also covered in the SDLC Procedure:

1. Design reviews
2. Unit testing
3. Integration testing
4. Verification testing
5. Static analysis
6. Code reviews
7. Code control
8. Bug tracking

Services

Software Quality Policy

Software Verification and Validation (V&V)

Software Quality Assurance (SQA)

Risk, Safety & Hazards Management

21 CFR Part 11

User Manuals

Training

Software Development