Medical Software Engineering
Enea is a proven leader in developing, testing, and certifying safety- and life-critical software and systems – high-reliability engineers for high-reliability projects. Our processes and expertise have been successfully deployed in over 100 critical systems, including medical devices such as:
- Infusion pumps
- Defibrillators
- Kidney dialysis machines
- Cardiac monitoring devices
- Medical instruments
- Cellular analysis systems
- Noninvasive monitors
Enea’s SEI Level 4, FDA-compliant processes and engineering services are available to augment your engineering efforts and streamline the development process throughout all phases of product development, from a single lifecycle step, to an entire project. These services include:
- FMEA and FHA, safety analysis/assessments
- Requirements definition
- Architectural analysis/definition
- Software design, code & test (functional and structural)
- Device drivers, BSPs, and commercial library/tool integration
- Communications protocol development and integration
- Project road maps defining all your work steps, risks, mitigation, strategies, and detailed process/tool/schedules for all phases of the medical systems lifecycle
- Technical project management training