ISO 13485 is an internationally recognized quality standard for quality management within the design, development, and manufacture of medical devices. ISO 13485 is recognized in major markets throughout the world including the United States, Europe, Canada, Japan, Australia, and more.
"Earning the ISO 13485 Certification demonstrates to our customers, partners, and investors that we are dedicated to quality at every level throughout our organization,"
ISO 13485 is based on ISO 9001, and includes additional requirements that are necessary to assure the quality of medical devices. ISO 13485 establishes standards for regulatory compliance and assists in helping companies provide improved product safety, increased efficiency, cost savings, and an increased ability to meet customer requirements.
The British Standards Institute (BSI) is Domain Surgical's ISO 13485 registrar. BSI is one of the world's most respected and comprehensive Notified Bodies with unrivaled expertise and experience in assisting its customers with regulatory and quality requirements for medical devices.
About Domain Surgical, Inc.
Domain Surgical is a privately held company based in Salt Lake City, Utah. The company has commercialized a product line of capital equipment and single-patient-