ISO 13485:2016 Quality Management System (Medical Device)

Description

SO 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.

Related posts:

2016 SPECIALIZED S-WORKS ENDURO 29 $ 5,900 ISO 13485 – Medical Devices -Quality Management Systems – Consultancy, Training & Certification Services. ISO 13485 – Medical Devices -Quality Management Systems – Consultancy, Training & Certification Services. ISO 13485 – Medical Devices -Quality Management Systems – Consultancy.