Understanding ISO 13485:2016
To understand the Medical Devices Quality Management System ISO 13485:2016
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
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
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