ISO 13485:2016 Certification

ISO 13485:2016 specifies requirements for a quality management system where an organization are in the business of medical devices and related services

When it comes to medical device manufacturing, the safety of the patient greatly depends on the quality and consistency of medical products, and ensuring efficiency, control and upkeep of QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.

Products of such companies which are involved to consistently meet customer and appropriate regulatory requirements. These organizations can be involved in one or more stages of process in the life-cycle of manufacturing medical devices and equipment’s, including design and expansion, manufacture, storage and distribution, installation and servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

This certification is essential and can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

The ISO 13485 standard is an effective answer to meet the thorough requirements for a QMS. Adopting the ISO 13485 provides a practical foundation for manufacturers to address the policies and obligations as well as demonstrating a commitment to the safety and quality of medical devices they are manufacturing or commissioning.