Insurgical®, Inc. Receives ISO 13485 Quality Management Certification for Single-Use Power Tools
Austin, TX, USA – March 23, 2015
Insurgical, Inc. announced today that it has achieved ISO 13485:2003 certification for its quality management system. BSI, one of the world’s leading certification bodies, awarded the certification.
ISO 13485:2003 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer requirements. Typically, it is a first step towards obtaining CE mark, the regulatory clearance requirement recognized in Europe and other countries that indicates that products meet EU safety, health or environmental requirements.
“Achieving the ISO 13485 certification has been a strategic priority for us that reinforces our commitment to quality and to our customers.”said Pete Aman, CEO of Insurgical, Inc. “We are now able to pursue CE mark, and ultimately to expand the reach of our power tools to customers worldwide.”
About ISO 13485:2003
ISO 13485:2003 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principals relate to customer focus, management, internal processes and external relationships.
About Insurgical, Inc.
Insurgical is pioneering the design and development of sterile, single-use, bone cutting tools for the orthopaedic and cardiac surgery markets. Insurgical tools are designed to provide surgeons with high performance, pre-sterilized, single-use cutting tools that increase operating room efficiency, ensure tool sterility for patients, and reduce hospital capital expenditures and reprocessing costs associated with reusable tool sets. Insurgical is a privately held medical device technology company, based in Austin, TX.
11002 Metric Blvd., Suite C
Austin, TX 78758
+1 (512) 318-2980