Awareness Training Program on Medical Devices - Quality Management System based on ISO 13485:2016

ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirements and allows the incorporation of applicable regulatory requirements within an organization’s quality management system.

• Basic Introduction to ISO 13485: 2016
• Relation ISO 9001:2015 / ISO 13485:2016
• Key issues addressed by ISO 13485:2016
• Integration of Risk Management ISO 14971 in ISO 13485

• Medical Device Manufacturers
• Quality Professionals
• Regulatory Professionals
• Internal and external Auditors
• Consultants and anyone involved with the implementation of the standard

Preferred to have basic knowledge in Quality Management system and / or experience in medical device, pharmaceutical operations.

• Gain insights on the ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes)
• Understand the relation ISO 9001:2015 / ISO 13485:2016
• Understand the key issues addressed by ISO 13485:2016
• Understand the integration of Risk Management ISO 14971 in ISO 13485

• No Examination. Certificate of participation will be issued at the endof the course.

1. When can I get the certificate?

Awareness Training Program on Medical Devices - Quality Management System certification will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?

One day before the commencement of the training program.

3. How do I pay the fees for training and examination?

Online mode

4. What are the benefits of the Awareness Training Program on Medical Devices - Quality Management System Program?

• Gain insights on the ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes)
• Understand the relation ISO 9001:2015 / ISO 13485:2016

• Understand the key issues addressed by ISO 13485:2016
• Understand the integration of Risk Management ISO 14971 in ISO 13485

5. Is there any refund policy for the paid fees?

Please refer to Cancellation and Refund policy page.