This intensive one-day course will introduce those who are new to medical device design and development to the critical elements of the human factors and usability engineering process. The programme shall cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.
The key regulations of the Medical Device Regulation and In-vitro Diagnostic Regulation, the Code of Federal Regulations from the USA (CFR 820.30 and Titles 50 and 56) and the UK MHRA Guidance for Human Factors and Usability Engineering shall be described, along with the specific processes and tools used in IEC 62366-1 and other ISO standards specific to special medical devices. A focus on ethics, consent and user safety shall be described, along with how ISO 14971:2019 is used alongside any human factors process.
The key areas of user research and design inputs shall be described along with verification and validation activities - formative and summative human factors studies and tests so that their purpose, methodology, process and outcomes are understood. Post-market surveillance human factors shall also be detailed since this area is becoming increasingly important to include. Finally, a basic understanding of ergonomics, anthropometry, user experience and biomechanics shall be detailed before an end of the day discussion on the wider use of human factors and usability engineering shall be discussed.
Attending this event will provide delegates with a comprehensive appraisal of key aspects of human factors in medical device design and an opportunity to discuss the complexities involved with an experienced industry expert.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of Attending
- Gain a comprehensive overview of the human factors engineering process
- Comply with global regulatory requirements and standards in human factors
- Learn about design controls and their interaction with human factors
- Review tools that are commonly used to determine human factors data
- Access key information on documentation management and systems
- Understand how risk should be managed from the perspective of the user
- Determine the benefits of human factors and usability studies
Certification:
- Certificate of completion
Agenda
Part 1: Introduction to Human Factors and Usability Engineering
- Defining human factors and usability
- Understanding what they cover
- Use errors, difficulties, close calls, frustrations
- Root causes
Part 2: The Common Processes in Human Factors Engineering
- Design controls and development methods
- IEC 62366-1
- MHRA Human Factors Guidance
- FDA Guidance for Medical Devices
- FDA Guidances for Pharmaceutical Products
- FDA Guidances for related aspects
- Related ISO standards for specific medical devices
- Post-Market Surveillance and Clinical Feedback
Part 3: Risk Management
- ISO 14971 Risk Management for users
- Hazard-related Use Scenarios and Task Analysis
- Human Factors Risk Assessment
- Use-related Risk Assessment
- Formative Usability Studies
- Summative Human Factors Tests
Part 4: Biomechanics, Ergonomics, Anthropometry and User Experience
- What are biomechanics?
- What is ergonomics?
- What is anthropometry and why it is important?
- User Experience for medical devices
- Discussion on human factors engineering and its value.
Speakers
Greg Thay,
Thay MedicalGreg Thay is owner and founder of THAY Medical, a Human Factors and Usability Engineering consultancy based in the UK and in Europe. He has worked in Human Factors since 2008 and has practised this specialism on many medical devices of all types. He has interviewed and evaluated thousands of people of all healthcare disciplines all over the world and completed many medical device developments from the human factors perspective.
Prior to human factors, Greg gained experience in orthopaedic device development, infusion therapy device development, wound care and superconductivity product development for large and small manufacturers. Since branching out into consultancy in 2010, he has grown his knowledge of design controls and human factors to ensure that he can train his staff to be competent in this field of human factors and usability engineering.
Who Should Attend
- Human Factors and Usability Engineering
- Project Management
- Device Development
- Technical Authors and Medical Writers
- Regulatory Affairs
- Quality Engineers and Managers
- Production Engineers and Managers
