Software Development Processes
With nearly 30 years of experience in developing medical devices and instrumentation, KMC Systems has developed a rigorous and proven lifecycle development process for designing software systems and interfaces, which includes:
- Combination of Iterative Waterfall and Incremental Models
- Rapid Software Prototyping
- Local and Remote Web-Based Diagnostics
- Wiki-Based Collaborative System
- Automated Build Process
- Defect Tracking Database
- Source Code Control
Combination Waterfall/Incremental Models
KMC Systems is ISO 13485 and ISO 14971 certified, and our software process is designed to support these standards. Additionally, our process supports development to IEC 62304. KMC Systems’ quality system includes procedures that meet the FDA’s QSR regulations, ensuring a smoother approval process.
Rapid Hardware/Software Prototyping
At KMC Systems, we maintain a library of proven software code, developed exclusively for medical products, that is used to help our customers rapidly bring projects to a feasible state. By re-using software that has been developed by our software engineering team, medical OEMs and start-ups can quickly conduct voice of the customer studies and focus groups, ultimately enabling them to bring marketable products to market faster.
Diagnostics
When an instrument or device encounters an error, internal software that can quickly diagnose the issue and, in some cases, rectify it immediately is critical to reducing downtime. Our skilled software engineers leverage their own expertise to design software for local and remote diagnosing of instruments.
Wiki-Based Collaborative System
We know how important it is for our customers to deliver their products to market on time. That’s why we’ve created an internal wiki-based collaborative system that allows our engineers and customers to share files and information, ensuring projects are completed and approved in a timely manner.
Automated Build Process
During the product design phase, it’s also important for our customers to have access to the latest versions of their software to ensure the development timeline is on track. At KMC Systems, we have automated that process so that the latest versions of software are updated nightly and accessible through our system.
Defect Tracking Database
To ensure smooth product development and a successful transition from design to manufacture, our software engineering team keeps a detailed log of all defects and their solutions. Customers can access this log at any time through our web-based portal. Additionally, we schedule regular meetings with customers to quickly triage any issues.
Source Code Control
According to FDA guidelines, all changes to medical software must be tracked. To help our customers navigate FDA approvals, we use industry standard products for tracking the entire source code change history of the medical instruments and devices we design.
Back to Software Design and Development.