ISO 13485:2016 Medical Devices Training
ISO 13485 applies to both manufacturers of medical devices and organisations that support medical device manufacturers.
It underpins the manufacturers’ duty of ensuring devices consistently meet customer and applicable regulatory requirements.
Foundation Course
(1 Day)
The requirements of the ISO 13485:2016 standard, how the standard interacts with ISO 9001, the European Medical Device Directive and the US FDA’s Quality System Regulation.
Internal Auditor Course
(2 Days)
Intended for medical device quality professionals. Learn the practices of effective QMS process audits in accordance with the ISO 13485 and
ISO 19011.
EU Medical Device Regulation 2017/745 (1 Day)
This course aims to provide learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry.
