Discount has been applied to the price above. VAT, if applicable, will be added.
Course Overview
Medical devices continue to grow in complexity with continuous innovations. In addition, device users are becoming less skilled and are often the patients themselves. As a result, the latest requirements in the Medical Device Regulation (MDR), emphasises the usability of a medical device. It is critical for device manufacturers to demonstrate their device is easy to use and will result in minimal errors of use.
In this training course you will gain a comprehensive overview of human factors and usability for medical devices. You will examine the standard IEC 62366 that outlines the process you must follow to ensure your device is easy to use. You will examine how to design and evaluate a device and discuss how to manage the risk of use errors.
The course begins at the time stated at the top of the page
The course is broken up into modules outlined below
There will be breaks between modules
Session 1
6 July 2023 | 3 November 2023 | approx. 120 mins | 10:00 AM UK
Introduction to usability engineering
What is meant by usability?
Review GSPR under the MDR
Examine the FDA regulations
Legal framework for manufacturers
Overview of usability engineering process in IEC 62366-1:2015
Risk management and usability
Design and development planning of your device
Review of the risk process and risk management activities
Examining how risk management integrates with usability
Why do use errors occur?
What is human error?
Case studies involving use error
Techniques to manage use error
Discussion and Q&A: There is time for interactive discussion where you can discuss your specific products and challenges.
Session 2
6 July 2023 | 3 November 2023 | approx. 120 mins | 1:00 PM UK
Usability evaluation
Step by step to delivering usability
Processing information
Summative evaluations
Usability documentation and integration
The Usability engineering file
Integration with design and Risk Documentation
US Documentation
Developing and implementing a usability engineering process Discussion:
Discussion and Q&A: There is time for interactive discussion where you can discuss your specific products and challenges.
Richard Young has over 25 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.
Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.
In a changing regulatory environment, communication with customers and end users is a critical element for all manufacturers in the life sciences sector. The content of labelling and internet communications is a vitally important part of the development and maintenance of compliance of all medical products. Richard has extensive experience in regulatory and quality roles for all classes of medical products and offers you a unique insight into the practicalities and requirements of human factors in todays markets.
The course is designed for those who must have an understanding of human factors and usability. These include professionals in design and development but also regulatory and risk managers responsible for device compliance. These include:
Product Design Engineers
Project Managers
Regulatory Affairs Professionals
R&D Personnel Risk Management Staff
Quality
Clinical Professionals
Could your team benefit from this course?
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
*
• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training
