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SchureMed Proudly Announces ISO 13485:2016 Certification

August 24, 2020

SchureMed is proud to announce our achievement as ISO 13485: 2016 Certified as of August 5, 2020.

ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Our organization is involved with design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

The ISO 13485:2016 Certification demonstrates SchureMed’s commitment to quality management processes and ensures best practices in everything we do.

SchureMed ISO 13485:2016 Certification