Compliance with International and National Standards
ISO 13485 certification demonstrates that a manufacturer's quality management system has been assessed by an independent third party as conforming to the requirements of ISO Certification. This is especially important for medical device manufacturers exporting to markets like the EU, which requires all devices to be produced in accordance with certification, as well as the ISO 13485:2003 standard.
An effective quality management system is a critical foundation for streamlined operations that yield minimum waste and downtime, all of which contribute to increased productivity and profitability. A properly implemented quality management system can also help a company respond more quickly to customer needs and market changes, provide more accurate forecasts, and expand into new markets.