OrthoSensor, Intelligent Orthopedic Device Innovator, Receives ISO 13485 Certification | Orthosensor Inc.

OrthoSensor, Intelligent Orthopedic Device Innovator, Receives ISO 13485 Certification

OrthoSensor, Intelligent Orthopedic Device Innovator, Receives ISO 13485 Certification

Sunrise, FL (June 9, 2011): OrthoSensor, Inc., a leader in developing intelligent orthopedic implants and sensor-assisted surgery systems, announced that it has received certification from the International Organization for Standardization (ISO), meeting the requirements of the ISO 13485:2003 standard. The ISO 13485 standard represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

“We are pleased that the ISO has validated the quality of OrthoSensor’s management system for the design and manufacture of our intelligent orthopedic devices,” commented Jay Pierce, Chief Executive Officer of OrthoSensor. “As we prepare for the limited release of our first product, the OrthoSensorTM Knee Trial, we believe that our customers will be pleased to know that we have met the exacting requirements and standards of the ISO organization. We are committed to remaining at the forefront of the latest breakthroughs in quality process management.”

The ISO has certified that OrthoSensor has implemented and maintains a Quality Management System for the design, manufacture and distribution of orthopedic implants, as well as positioning and balancing support devices, remote monitoring devices and systems.

About OrthoSensor, Inc.

OrthoSensor, Inc., a leader in Sensor-Assisted Total Knee Arthroplasty develops and commercializes intelligent orthopaedic devices and data services that provide quantitative feedback to surgeons and hospitals. The company’s intelligent orthopaedic devices utilize advanced proprietary sensor and communications technologies, coupled with the company’s innovative software products, to facilitate evidence-based decisions in orthopaedic surgery – with the goal of improving patient outcomes and potentially reducing the cost of treating musculoskeletal disease.

OrthoSensor® and VERASENSE™ are trademarks of OrthoSensor, Inc.

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