Many products now inlcude an increasing proportion of software to provide the desired functionality and while the process of product development for hardware and software broadly follows a similar lifecycle, software development needs a high level focus on the development quality assurance process due to the 'invisibility' of the structural elements of the software product.
Ledcourt Associates can help you to develop and implement processes inlcuding
- Software development lifecycle
- Software Change Management
- Software Configuration Management
- Software maintenance
In particular for Medical Devices we can provide expertise on the processes needed to meet the requirements of EN62304.