Our expertise provides an 'end-to-end' solution that focuses on:
- Determining and documenting an effective design specification that meets your product requirements
- Delivering functional prototype software within tight project schedule constraints
- Integration, refinement, and debugging of prototype software with associated documentation and unit testing
- Assistance with verification of design and usability relating to software functions and performance
- Management of software deployment activities including training, process validation, and risk monitoring
We are very comfortable operating within an IEC 62304-based software lifecycle process and have many years experience delivering software solutions within medical device regulations.