We Create Medical Devices

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.

Plan

PLAN

Specify

SPECIFY

Architect

ARCHITECT

Design

DESIGN

Prototype

PROTOTYPE

Verify

VERIFY

Validate

VALIDATE

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.

Life Support Ventilation

Engenious breathed fresh design into a life-support critical-care ventilator, bringing holistic solutions including human factors, labeling, mechanical, electrical and embedded software to bear.

Mechanisms

Engenious spun up a compact, battery-powered handheld device with mechanisms that apply topical nanoparticles in-clinic for a medical startup partner.

Electrosurgical Systems

Engenious blended into a client’s RF electrosurgery team to create real-time feedback control and measurement system for a 300W surgical system. Find out more >

Take It From Our Clients:

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

Electrical Engineering

Sensors, analog signal conditioning, power supplies, amplifiers, motor control, FPGA, wireless, high-reliability electronics

Mechanical Engineering

Mechanisms, enclosures, thermal design, fluid handling, gas control, GD&T, optics, high-reliability mechanical design

Embedded Software

Real time microcontrollers, PID control systems, network, device drivers, filters, audio/video, wireless, high-reliability software

Systems Engineering

Requirements, architecture, risk management, and expert technical coordination of highly-integrated engineering teams

Industrial Design

Interactive products, handles, grips, controls, indicators, models, and user-centered holistic design that works from the inside-out and outside-in

Interaction Design

Graphical user interfaces, multi-language, iconography, information hierarchy, UI navigation, wireframing, concept development

Project Management

Experienced planning and coordination, collaborative progress management, risk management, budget controls

Graphic Design

Labeling, packaging, instructions for use, clinical education and support materials, identity and exhibit graphics applications

Boutique Manufacturing

Work instructions, process validation, rapid, short run, production-equivalent, device history records, controlled environment

Regulatory Compliance

Device classification, regulatory planning, quality system compliance, notified body evaluation

Human Factors

Planning, formative and summative studies, design for usability with a focus on user needs, intended uses, and use cases

Test Engineering

Test planning, test procedures, execution, records for complex electro-mechanical devices

OUR CREDENTIALS

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

Let's Talk

Great teamwork starts with a conversation!