MEDICAL DEVICE PRODUCT DESIGN • ELECTRICAL DESIGN • MECHANICAL DESIGN • SOFTWARE DESIGN • PRODUCT DEVELOPMENT
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ISO 13485 FM 546200 • ISO 14971 RM 546203 • FDA REGISTERED

Spine Arthroplasty Power Injector

Disc Dynamics Incorporated (DDI) was founded as an orthopedic spine company to provide patients and physicians with a minimally invasive surgical alternative for treating degenerative disc disease.

DDI contracted Devicix to develop a powered surgical instrument for their proprietary polymer that is injected into the spine disc space. Devicix had the expertise in orthopedic products, medical electronics, and medical device software.

Medical product design by Devicix:

14 months to first human use
Class III medical device
Medical electronics and medical device software per ISO 62304
Closed loop embedded system design
Powered surgical instrument
Electronics packaging
Human factors and graphical user interface (GUI)
Contract medical device manufacturing
Medical device software validation
Medical device electrical safety testing (IEC 60601)

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