
Orthocare Innovations. A leading research and development company developing the latest in prosthetic and orthotic technologies.
Capabilities
OI is experienced in all aspects of medical device product development ranging from concept through clinical testing and regulatory approvals. We can work independently, or seamlessly integrate with customer engineering teams to support any of the following aspects of product development:
Product Design
Orthocare works with customers to translate product requirements into design specifications. We also support intellectual property, product economic and reimbursement and manufacturability considerations.
Device Development
Orthocare has complete engineering development teams including, project management, mechanical, electrical, materials, software and manufacturing capabilities.
Mobile Connectivity
We have a strong track record in developing medical device mobile applications for both iOS and Android operating systems. Orthocare’s Galieo™ platform can be adapted to meet customer requirements in a timely and cost-effective manner.
Clinical Evaluation
Orthocare has extensive experience in product evaluation and clinical study design and support. We engage directly with both clients and third parties to evaluate product designs from laboratory testing through to full patient trials to ensure device optimization and functionality.
Regulatory Support
We utilize both client and internal design controls to ensure compliance with FDA, ISO and CE requirements.
Transition to Manufacturing
We work with customers to identify and qualify vendors, as well as with internal production teams to effectively transfer technologies and know how in preparation for manufacturing.