ISO 13485

ISO 13485

ISO 13485 is an international standard that specifies requirements for medical device manufacturers. The main goal of ISO 13485 is to provide a harmonized model for quality management system requirements in the international market. ISO 13485 compliance is therefore of critical importance. A quality management system is critical to ensure your medical product will be manufactured to your specifications for safe intended use every time. With every product submission, the regulatory bodies require proof that your product has been manufactured under a certified quality management system. With the UL ISO 13485 registration service, you will not only have the confidence that your system meets global quality system accreditation requirements, but you will also save time and resources by taking advantage of our local, integrated audits, no matter where in the world your manufacturing, design, packaging, or distribution is done.