ISO 13485:2016 Medical Devices - Quality Management systems
Quality performance of medical devices and compliance with applicable regulatory requirements to planned arrangements are significant aspects in providing reliable quality services to the society and meet customer’s expectations. Medical devices — Quality Management systems provide an opportunity for organizations, to adopt process approach and plan-do-check-act, to effectively plan controls in the life cycle of medical devices comprising design and development, production, storage and distribution, installation, or servicing and enhance compliance to customer expectations.