“For any business selling a device in the USA, the onus is now very much on medical device provider, whether the device in design is a more complex piece of equipment, to keep all the users safe”.
SENIOR MARKETING DIRECTOR, MEDICAL DEVICE EQUIPMENT MANUFACTURER, DENMARK
“Human factors is a part of everyone’s job role, not just those who have it in their title”.
VP, R & D GLOBAL MEDICAL DEVICE MANUFACTURERS, UK
Dr Robert North
Updated in 2016 to cover the update to the publication of the FDA (CDRH) document “Applying Human Factors and Usability Engineering to Medical Devices”, the 2017 course will include the updates to the MHRA and FDA (CDER) draft publications and the latest ISO publications regarding Human Factors.
This 3-day event will inform you of the Regulatory requirements of FDA, more specifically the interpretation from the Centre for Devices and Radiological Health (CDRH) Human Factors Pre-Market Review Team, as they relate to human factors and the process of applying human factors in design controls and the FDA approval process during the design of a medical device.
The Moon on a Stick is an innovation management firm that guides people through a journey that makes innovation simpler to understand and use.