Usability requirements course
Usability Requirements Course
Usability and Human Factors Training Course
This interactive course, which is delivered over one day, will provide participants with a thorough understanding of IEC 62366, its practical application, and implications for both Active Medical Devices (AMD) and non-active medical devices. The course aims to assist organisations in understanding how to align with regulatory provisions from both MDR and UK MDR 2002, and generate a usability process to ensure the safety and efficacy of a device.
Participants will depart with the understanding and confidence to produce, enact and document a usability engineering framework whilst enhancing the product design, regulatory compliance and patient safety.
- Comprehend how the MDR/UK MDR 2002 is interconnected to IEC 62366
- Be able to define the key terms and definitions in the standard
- Define and apply the usability engineering requirements
- Recognise the methodologies employed in undertaking usability assessments
- Develop and implement a usability engineering process
- Identify and manage key usability documentation and deliverables
Learning Objectives/Course Outcomes
At the end of the course, participants will be able to:
Who Should Attend?
This course is suitable for all professionals connected to the medical device design, compliance, or risk management sectors, such as:
Regulatory and Quality Assurance Managers
Design and Development Engineers
Risk Management Persons
Project Managers
Course Outline
- I. Introduction
- II. Requirements from the Standard
- III: requirements for active devices and links to the IEC 60601-1
- IV: Implementing the requirements
- V: Conclusion
- VI: Assessment/Test
Prerequisites
To gain the most benefit from this training, participants should have a basic understanding of:
- ISO 14971 and Quality Management Systems
- The Medical Device Industry and its regulatory landscape
Training
MDSSPRO trains using an interactive approach, practical exercises, and real-world case studies for effective and engaged learning. Our knowledgeable tutors will guide you through each step of the process, many of whom have experience facilitating medical device compliance and are focused on ensuring that you can put theoretical concepts into practice.
The training can be delivered both online and on-site, providing flexibility to meet your team's preferences.
Online Training Course - £400 per person
This will include access to online tutors experienced in medical device compliance who are available to provide ongoing support, answer any questions, and assist with the course content.
We have special student pricing - for more information, please email admin@mdsspro.com
On-Site Training
Custom training sessions can be offered on your company's premises to ensure the content is relevant to your products and regulations. For more information on numbers, costs and timing, please email admin@mdsspro.com.
Why Use MDSSPRO?
MDSSPRO is a specialist in training and consultancy in the medical device sector, uniquely combining regulatory understanding with practical, industry-focused learning. Our trainers have experience with leading companies such as TÜV SÜD, SGS, UL, and Intertek, and our content reflects knowledge of current expectations of competent authorities and notified bodies.
All of our courses are designed with relevance, flexibility, and value in mind – supporting document examples, compliance practice and a supportive learning environment.
Let’s Build Compliance Confidence Together
Partner with MDSSPRO to ensure your medical devices meet the highest regulatory standards. From tailored training to expert auditing, we’re here to guide you every step of the way toward full MDR compliance.
