Areas of expertise

  • DESIGN & DEVELOPMENT

    From a napkin sketch to a working prototype, the design and development of your project is our top priority

  • Regulatory pathways

    Every medical device sold in the US must be cleared by the FDA. Each country has their own set of these regulations. We can help you navigate them.

  • quality control

    ISO 13485 documentation, testing & inspection plans to ensure your product meets the highest, repeatable, standards of quality

  • Project management

    Experienced project management to deliver your expectations when you expect them

SPECIFIC AREAS OF DESIGN EXPERIENCE

Previous clients' product descriptions

OrTHOPEDICS

Bone screws, plates, nails

drug delivery

Mechanically or electromechanically driven injectors

large electro-mechanical systems

Drive systems, such as linear/rotary travel for large devices

navigational systems

Neurological and orthopedic targeting systems

early childhood devices

NICU treatment devices

physical therapy

Devices for physical therapists