Extremity Medical, LLC receives ISO 13485 certification for its Quality Management System
Extremity Medical, LLC, an orthopedic device company, announced today that the company has recently received the internationally recognized ISO 13485:2003 certification for their Quality Management System. This major milestone certifies that the company is in compliance with the stringent requirements of ISO 13485:2003 for the design, development and manufacture of hand, wrist, foot and ankle fixation and arthroplasty implants. The certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements, as well as many other regulatory requirements found throughout the world, and demonstrates a commitment to quality.
ISO 13485:2003 specifies the requirements for a quality management system in situations where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
Jamy Gannoe, President and Co-Founder of Extremity Medical, stated, “We are pleased to have reached this important and necessary milestone through the outstanding efforts of our Quality Assurance Team, with strong support from the rest of Extremity Medical. This certification validates our commitment to delivering quality products around the globe and represents a major step forward for our small but formidable company.”
