Why you should attend
By attending this seminar you will:
- Understand the requirements of IEC 62366 and FDA Human Factors Guidance
- Know how to provide the regulators with specific usability data for your device
- Understand human factors and the design process
- Learn how to validate combination products
- Consider human factors and risk
- Discuss generic combination products - ANDAs and HF
- Find out what HF data FDA require for biosimilars
The course runs from 09.30 to 17.00 BST (British Summer Time).
Speakers
Mr Richard Featherstone,
Human Factors Director ,
Medical Device Usability LimitedRichard Featherstone is Human Factors Director of Medical Device Usability Limited, a specialist human factors consultancy that works exclusively with new and emerging medical technologies.
He has been designing and conducting human factors studies for over 10 years, and his experience includes a wide range of drug delivery technologies including inhalers, auto-injectors, nasal sprays and associated devices such as tele-health systems. He and the MDU team regularly test in the US, UK, Europe and Australia and undertake formative and summative testing for some of the world’s largest pharmaceutical and medical device companies as well as small start-ups.
Based in Cambridge, MDU has grown rapidly to become Europe’s largest specialist medical HF consultancy with clients around the world. Over 10 years of testing has meant that Richard has built a considerable body of knowledge of the practical aspects of designing, undertaking and reporting of both types of testing.
Who Should Attend
This event will be beneficial to those working in the following areas:
- Engineering and device development
- Packaging
- Regulatory affairs
- Quality systems
- Quality assurance
- Risk management
- Marketing
- Usability and human factors engineering
