Our staff of developers all have experience in the medical device industry, and are believers in the Intertech product development processes which are compliant with the FDA Quality System Regulations (QSRs).
Our engineers have designed and developed products on a complete turn-key basis, collaborating with trusted partners in disciplines in which we are not expert. Our engineers often are contracted to supplement our clients’ engineering staff by adding expertise where the client is lacking, or by adding additional manpower to work through a “peak need” period. Our development staff also frequently contracts to maintain our clients’ legacy devices, addressing field issues, or extending the market life of the device by adding new features.
Our staff have worked as hands-on engineers who design client products; have trained client engineers; have consulted with client management in these disciplines, and have simply supplemented the clients’ existing engineering staff.
Software Design and Development
Our software development process is lifecycle driven. Our software developers work in concert with the Intertech or client validation team to systematically develop and document:
- Product Level (i.e. User and Marketing Requirements)
- Software Requirements
- Architectural and Detailed Design Documents
- Source Code in a Variety of Languages for a Variety of Operating System
Additionally, our software development staff is proficient in assisting the software validation effort by leading or participating in:
- Software Requirements, Design, or Code Reviews
- Independent Party Unit Level Testing
Electronics Design and Development
Our electrical engineers also are guided by a lifecycle development process. Our EE’s have expertise in:
- Electronics Requirements Development
- Schematic Design
- Board Layout
- Prototype Assembly
- Debug and Board Repair