The International Organization for Standardization (ISO) has certified OrthoSensor with ISO 13485:2003 standard.
OrthoSensor develops orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery.
The company claims its instrumentation and implants, which use sensor and wireless communication technology, are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.
ISO has certified that OrthoSensor has implemented a Quality Management System for the design, manufacture and distribution of orthopedic implants and positioning, balancing and alignment support devices, remote monitoring devices and systems.
OrthoSensor CEO Jay Pierce said as they prepare for the limited release of first product, the OrthoSensor Knee Trial, they believe that their customers will be pleased to know that they have met the exacting requirements and standards of the ISO organization.