CSA Group is a global certification body headquartered in Toronto, Canada. We have offices and laboratories around the world, not only in the United States and Canada, but also in Europe and Asia. Of course, we also have a base in Yokohama, Japan, and we will help our customers to enter the global market through certification services.
With decades of experience providing testing, inspection, and certification services for the healthcare industry, CSA Group provides the support and guidance you need to help you meet your compliance requirements, offer your customers peace of mind, and ensure a thorough and efficient certification experience.
In addition, we provide testing and certification services for the IEC80601 series of standards for medical robots, helping to realize rapid market introduction.
In the CSA Group, six locations, including the Yokohama laboratory, are registered as US FDA ASCA accredited laboratories.
By using this accredited laboratory to conduct standard compliance tests, create test reports, and submit them to the US FDA, we can expect to proceed with FDA reviews more efficiently.
Furthermore, as a new initiative for the medical device industry, the CSA Group will begin offering quality management system audit and certification services based on the ISO 13485 standard. ISO 13485 is a quality management system standard required for the design and manufacturing of medical devices.
Conforming to and maintaining compliance with this standard is highly effective in demonstrating that a company meets the requirements which is obliged by medical device regulators in many countries and regions around the world.