Development of Next Generation Sequencing (NGS) Companion Diagnostic Device
The RND Group recently completed a project with an industry-leading genomics company to develop an FDA-regulated Companion Diagnostic Device to aid in the identification of cancer patients who qualify for acceptance into clinical trials. The clinical trial’s purpose was to test the effectiveness of a specific pharmaceutical drug in treating Diffuse Large B-Cell Lymphoma.
Full Lifecycle Services
- Analysis
- Requirements definition
- Software design
- Software implementation
- Software unit and integration testing
- Software verification
- Software tool validation
Capabilities Applied
- FDA Part 820, Part 11
- Results algorithm design and development
- Software risk analysis and management
- ISO 13485, HIPAA, IEC 62304
- User Interface design and development
- Project management
- Software validation
- Software life cycle processes
- Requirements development and management
- Software verification
