OrthoSensor, Inc., Intelligent Orthopedic Device Innovator, Receives ISO 13485 Certification
Published: Jun 10, 2011
SUNRISE, FL--(Marketwire - June 09, 2011) - OrthoSensor, Inc., the 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 OrthoSensor™ 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 and positioning, balancing and alignment support devices, remote monitoring devices and systems.
OrthoSensor, Inc. (www.orthosensor.com) is an innovative medical device company developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery. OrthoSensor's intelligent orthopedic devices utilize advanced sensor and wireless communication technology with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company's intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.
Stephanie Marks for OrthoSensor
Rachel Kessler for OrthoSensor