ISO Autonomous Body

The International Organization for Standardization is a worldwide autonomous body for setting various global standards for quality management. It comprises of representative standardization organizations from various nations. Established in 1947, the ISO frames and promotes worldwide industrial and commercial standards.

ISO 13485:2016 Certification

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. Such organizations can be involved in one or more stages of the life-cycle, including 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.

ISO 13485:2016 For Whom

This approach is not only followed by Medical Device Manufacturers but also supporting organizations such as Subcontractors, Suppliers, European Authorized Representatives, specialized Consulting firms etc…  

For Certification and Implementation of the Standard in your organization, contact us at +91 7566 355 111 or you can fill the form here, Our experts will call you and guide for Successful Certification.

Benefits of ISO 13485 Certification

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

• Increase access to more markets worldwide with certification
• Outline how to review and improve processes across your organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations