In the medical equipment industry, the requirement for operational reliability and precision is extremely high. Enea is a proven leader in developing, testing, and certifying safety- and life-critical healthcare 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
• ECG, mammography and ventilation units
• Cardiac monitoring devices
• X-ray imaging systems
• Medical instruments
• Chemical analysis equipment
• Cellular analysis systems
• Noninvasive monitors
We work closely with equipment makers to establish the long-term relationships needed to understand their quality requirements and processes. Whether providing an external development department, or helping equipment makers develop their own expertise, our consultants work closely with our customers to enhance quality, reduce life-time development cost, and slash the time between concept and product launch.
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.
Our consultants are experts in all aspects development of hardware (PBA, FPGA, digital signal processors) and software design, integration, testing, verification, validation, certification, and quality management. We also provide extensive training, mentorship, and project management services, all geared toward increasing quality while reducing cost and time to market.
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