Our product design and development process, and our manufacturing facility are certified and audited to ISO 13485:2003 and ISO 9001:2008. This includes the design and development provision of ISO 13485:2003.
ISO 13485:2003 is an internationally recognized quality management standard for the design and production of medical devices. In addition to mandating process and product safety, this standard focuses on the key aspects of inspection and traceability, documentation, design process control, and risk management. It is important to note that ISO certification is not a one time exercise but an ongoing commitment. Our staff works to maintain this certification every single day.
The ISO framework is just one of the tools we use to ensure that we consistently meet product quality objectives, customer specifications, and regulatory requirements. In addition to ISO 13485:2003 and ISO 9001:2008, we are a registered US FDA manufacturer. We provide metrology data, material certificates, and documentation of specified performance parameters with all shipped product.