Medical Human Factors Engineering: An introduction to Human Factors and how to meet the requirements for FDA and EMA submission
Human Factors Engineering is an essential part of medical product development and has progressively become a major focus of regulators over the last decade, most notably the US FDA. Human Factors studies are now often a key part of the medical product review process in the US and EU, including for drugs/ biologics. There are now specific compliance requirements for Human Factors Engineering and failure to comply to current requirements has caused many companies to suffer significant submission delays, complete responses and compliance citations, including warning letters. It is therefore critical to understand and apply the necessary Human Factors process during medical product development.
This seminar will cover an introduction to the discipline, an overview of the current regulatory expectations and examples of ‘lessons learned’ illustrated by real-world case studies and is provided free of charge by medHF (www.med-hf.com), a provider of Human Factors Engineering services to many of the world’s leading medical device and pharmaceutical companies.
To attend the event you can contact the email firstname.lastname@example.org
Beginning date and hour: 20/02/2017, 10.00h
Ending date and hour: 20/02/2017, 12.00h
Organizer: MHF- Medical Human Factors
Place: Edifici Torres R+D+I, TI 4
Host: Thiago Figueiredo