ISO 13485 – Medical Devices – Quality Management System

Organisations that are providers of Medical devices and services are required to demonstrate their ability to provide their products and related services that consistently meet customer and applicable regulatory requirements. ISO 13485:2016 specifies requirements for a quality management system for such organisations. These organizations may 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).

TUV India Training Academy provides various training programs to achieve the required knowledge & skills among the organization’s employees to achieve its goal of implementing Medical Devices – Quality Management System & its integration with other management systems.

The following training courses are offered:

• Awareness training programs for Senior Management teams to drive the implementation of Medical Devices Quality Management System
• Awareness training programs for the employees at all levels to develop understanding of the requirements of ISO 13485 useful for implementation
• Internal Auditor training programs to develop a team of internal auditors
• Training for integration of Medical Devices Quality Management Systems in to other management systems
• CQI/IRCA registered Auditor/Lead Auditor training courses for developing team of competent Internal/external lead auditors