Full Lifecycle Software Development of IHC Slide Staining Instrument
The RND Group, a Gener8 company, has been working with an industry-leading testing company that provides lab automation solutions for immunohistochemistry (IHC) slide staining for pathology and research labs. The client engaged with RND Group to create the user interface and instrument control software for their latest sample preparation platform.
Challenges
- Integration of features from two existing slide staining software solutions (one for IVD and one for RUO).
- Integration with a new lab automation platform with expanded capabilities.
- Lack of critical details in existing documentation, requiring significant reverse engineering.
- Ensuring compliance with regulatory requirements, specifically IEC 62304 and FDA’s 21 CFR Part 820
Soultions
- Deployment of a cross-functional team of software engineers, quality engineers, a technical leader, and a project manager for complete outsourced software development.
- Dynamic staffing of the team with 2 to 10 internal RND resources to manage workload fluctuations.
- Development of a new sample preparation instrument with updated features and higher capacity without the need to hire a full software team.
- Creation of a complete design history file to ensure regulatory compliance with IEC 62304.
- Improved maintainability of the new platform.
- Establishment of historical reference for future use.
