This one-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device. The format for the day will be interactive with the presenter sharing his experiences as a specialist with extensive knowledge and understanding of the requirements of IEC 62366 and FDA human factors guidelines. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study
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
- Ensure you test the right product
- Learn how to get the human factors right for combination products
- Ensure you get the right study participants
- Find out how to set up simulated use environments
- Consider the labelling, packaging and the instructions
- Discuss training strategies for your device
Who should attend
This seminar will be beneficial to those working in the following areas:
- Engineering and device development
- Regulatory affairs
- Quality systems
- Quality assurance
- Risk management
- Usability and human factors engineering
Welcome and introductions
Guidance, standards and the law – what MUST be done
- Requirements of IEC 62366 and FDA Human Factors guidance
- What is the legal and regulatory status of human factors
- How do the European and US requirements compare?
- Which guidelines should I be following for my product?
How to provide the regulators with specific usability data for your device
- What are the regulators looking for?
- What are their requirements?
- Successful applications – how to maximise the chance of a successful review
Starting at the right place
- How and when should you start planning your human factors study?
- How and why are combination products different
- How to get the Human Factors right for them
- ANDAs – what human factors data do I need if I am submitting an ANDA?
How to pass the validation study
- Do I need to do a validation study?
- How do I know if my product will pass the validation?
- How to avoid the common pitfalls in validation studies
- US versus Europe – do I need to run a validation study in both locations?
Setting up a HF study – who are your users?
- Key points to consider when setting up a HF study
- Your intended users may not be who you think they are
- How to establish the users of your product
- How do you make sure you get the right study participants?
Testing the right product
- How do you decide what to test?
- Ensuring you avoid testing the wrong prototype or the wrong design iteration
Simulated use environments
- Using higher fidelity test environments
- Important environmental factors to consider
Labelling, packaging and the instructions for use
- Packaging, labelling and instructions are part of the device user interface
- Testing the packaging and labelling
- What needs to be tested?
- How to test successfully
- Will your users be trained to use your device?
- What training materials will you provide?
- Is the device a home-use device, in which case do you need a no-training group?
Frequent versus worst case scenarios
- Which scenarios should you include?
- Do you need to test every possible scenario?
We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.