ObjectivesTo understand the Medical Devices Quality Management System ISO 13485:2016
Content includesProvide 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 attendPersonnel working in the Medical Technology Industry
No training dates available at the moment.