Medical Device Development
What We Do
SterlingTech Software performs custom medical device software development including Verification and Validation for FDA approved devices using skills such as Image Analysis or Segmentation, GUI development, embedded systems, and Windows development.
- Full life cycle development and test
- Requirements capture
- Risk planning and hazard identification
- Architectural design
- Software design
- User Interface Design
- Implementation of code
- Test
- Software Verification & Validation
- Structural Coverage
- DHF Remediation
- Reverse Engineering documentation
- Independent reviews
- Software Quality System Review and Update
- Training on FDA/CE compliant software development processes
- Provide guidance, artifacts and support for FDA/CE submissions
- Provide a hardware lab to support debugging of hardware interfaces
- GMP Manufacturing Support
- Project management
- Detailed and timely status updates
- Accurate schedules
Your medical device issues are our chief concern. We will solve them,
from concept through submission.
