Quality Training

ISO 13485:2016

Objectives

To understand the Medical Devices Quality Management System ISO 13485:2016

Content includes

Provide an insight to the use of ISO13485 as the basis for a Quality Management system implemented by medical device manufacturers

• Review the requirements of ISO13485 and make comparisons to ISO9001:2012 and 13485:2012
• Give participants an understanding of ISO13485 and its alignment to FDA’s Quality System Regulation
• Assist participants in the relationship between ISO13485 and ISO14971- Application of risk management to medical devices
• Identify what ISO13485 requires and also what is not required within the standard
• Clarify process management in the context of the requirements of ISO13485
• Give basic audit techniques in meeting the ISO13485 requirements.

Who should attend

Personnel working in the Medical Technology Industry

Upcoming dates:

No training dates available at the moment.