Rapid Process in 8 steps
Our specialties include Electrical, Mechanical, and Embedded Software systems, FDA Class I, II, III, and PMA Devices, and Internationally-Distributed Devices.
Transfer to Production
TRANSFER TO PRODUCTION
Our Experience Produces Results
At last count, our portfolio included over 35 commercially-released products. Because of our team’s work, there are hundreds of thousands of medical devices operating reliably in the field, improving lives worldwide. The life-saving nature of our work drives us to move with a sense of importance, urgency and satisfaction.
Take It From Our Clients:
The Engenious team’s partnership has been instrumental to the progress we have made thus far. We value their knowledge, creativity, flexibility, preparation, and willingness to think outside the box to get things done. Their insight and experience has been vital to moving the program forward.
Scott Summersgill,Director of Manufacturing, Sienna Biopharmaceuticals, Inc., Westlake Village, CA
Engenious moved our product development forward with their ability to quickly design experiments and build and test precision mechanical medical devices.
Cary Dikeman,CEO, Nexus Medical, Lenexa, KS
I have worked with people on the Engenious team a number of times over the past 15 years on both class II monitoring and class III cardiac devices. I have been consistently impressed by their med device knowledge, the timeliness and quality of their deliverables, and the breadth and depth of their experience.
Pete Andriola,Director of Electrical Engineering, St. Jude/Thoratec, Pleasanton, CA
We are built to be rapid and integrated!
We have a Micro-Electronics Lab, a Model & Machine Shop, a CNC Milling Machine, and SLA and FDM 3D printers to build, test, and iterate quickly
Our Team is Our Secret Weapon
We have it covered and we’re serious about getting our important work done quickly, and with excellence
Our team’s recent projects include an impressive list, if we do say so ourselves.
- Life Support Ventilator
- Video Quadcopter
- Heart Pump Accessories
- Wearable Electronics
- Pulse Oximetry
- Glucose Meter
- RF Electrosurgery Unit
- High-End Consumer Goods
- IV Therapy
- Surgical Lighting
- Drug Delivery
- Surgical Tools
- Vascular Compression Devices
- Wireless HD Video Streaming
- Blood Diagnostics
- Neurological Assessment
Speak For Themselves
- A culture that is built on the letter and intent of standards
- Proven Quality Management System
- ISO:13485 and 21 CFR 820 compliant
- Rapid production-equivalent devices in house
Great teamwork starts with a conversation!