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ISO 13485:2016 Requirement
Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.
This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with with ISO 9001:2015, the European Medical Device Directive and the US FDA's Quality System Regulation. The relationship with ISO 14971, Application of Risk Management to Medical Devices is also explored during the course.
This course will help you:
On completion of this training, participants will be able to:
ติดต่อเราเพื่อดูว่าเราจะสามารถช่วยแนะนำคุณบนเส้นทางสู่ความสำเร็จในการดำเนินงานอย่างยั่งยืนได้อย่างไร