Design Services
Summa Design has provided contract services to Fortune 500 companies, as well as small startups. We offer a broad spectrum of services to the medical device community, but are not limited to one field or specialty. Our engineers and managers have an unsurpassed depth of experience in medical device design, development, prototyping, quality systems, regulatory issues, and transfer to manufacturing.
We can assist you in any phase of development... from concept, design, and engineering to design verification, compliance testing, and quality assurance. Our regulatory and quality experts will help design your quality system or audit your existing system for FDA and international compliance. We can also help with preparation and review of your 510(k) applications prior to submittal.
SAMPLE PROJECTS
In-Vitro Diagnostics
ICU Monitoring Systems
Handheld wireless devices
Spinal Surgery Monitoring Devices
Diabetes Management
- Continuous Glucose Monitors
- Infusion Pumps
- Wireless PDA card to interface with Insulin Pumps and Monitors
Diagnostic Imaging
- CT Imaging systems
- Brain Activity imaging
Brain Functional Analysis
Cardiac Functional Analysis
Long-term Monitors
Embedded controllers
PDA-based systems
Physiological Stimulus Devices for Brain Activity Studies
Respiratory Therapy
Biomagnetometers for analysis of the brain’s magnetic fields
Low-cost cardiac and respiratory sensors
SUMMA'S CAPABILITIES
Electrical Engineering
- Board layout
- Power budgets
- FPGA
Software Engineering
- Applications
- Databases
Firmware Engineering
- Embedded controllers
- Drivers
- PIC controllers
- Motor drivers
- RF transceiver control
Mechanical & Plastics Engineering
- Low volume enclosure designs
- High volume enclosure designs
- Plastics and chemical resistance studies
- Heat studies
Industrial Design
- Mockups
- Ergonomic studies
- Design for High Volume Production
- Design for Low Volume Production
Our Regulatory staff will help you through the FDA approval process by tailoring an approach to your particular device. We have authored successful 510(k) applications for a diverse range of devices, from brain scanners to surgical laser systems and stimulus devices.
Need help setting up a compliant quality system? We can help design a quality system that not only meets US and international standards, but fits your business model.
Quality System Setup and Auditing
FDA 510(k) Authoring/Coauthoring
Combination Devices
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Summa Design’s engineers can develop prototypes of your ideas for demonstrations and proof-of-concept studies. Our newly established in-house production facility is perfectly suited for low volume production runs.
Mid and high-volume production runs can be handled by one of our various production partners, located both domestically and off-shore.
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