MEDICAL DEVICE PRODUCT DESIGN • ELECTRICAL DESIGN • MECHANICAL DESIGN • SOFTWARE DESIGN • PRODUCT DEVELOPMENT
REGULATORY SUPPORT • QUALITY ASSURANCE • INTELLECTUAL PROPERTY • MEDICAL DEVICE CONTRACT ENGINEERING
ISO 13485 FM 546200 • ISO 14971 RM 546203 • FDA REGISTERED

Trauma Implants with Powered Surgical Instrument

Dr. Ramon Gustilo, a pioneer in orthopedic trauma, wanted to commercialize his novel orthopaedic drill technology that reduces x-ray exposure during fixation of an intra-medullary nail by making distal screw locking easier and more reliable.

Devicix was engaged to commercialize this proprietary technology into a surgical instrument that would be suitable for both US and OUS markets. Expertise was required in medical electronics and medical device software.

Medical product design by Devicix:

Prototype to clinical trials in 18 months
Class II medical device, FDA approved
Complete medical product design history file (DHF)
Surgical drill technology development
Medical electronics and medical device software (ISO 62304)
Disposable medical product design
Testing of orthopedic implants (ASTM)
Medical device electrical safety testing (IEC 60601)
Sterilization qualification of disposables
Cadaver validation of medical products
Medical product contract manufacturing

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