Usability Requirements

Our medical device usability course

This 1 day training course - Usability Requirements - gives participants an in-depth knowledge of IEC 62366 requirements and its application.

 It guides organisations through the regulatory requirements for:
  • active medical devices
  • non active medical devices
It focuses on MDR compliance and explains how businesses can guarantee the safety claims of medical devices.  To enrol, please contact Medical Device Software & Sterilization Professionals in Lee-on-the-Solent, Hampshire today.  We operate worldwide.

Learning objectives / course outcomes

By the end of the course, participants will be able to:

  • Identify the links between MDR and IEC 62366
  • Explain terms and definitions
  • Define the usability requirements
  • Identify the methodology used
  • Develop a usability engineering process
  • Define the key documents of the usability file

Who is the course suitable for?

  • Regulatory and quality assurance managers and personnel
  • Design and development managers and personnel
  • Risk management personnel
  • Project managers

Course outline

  • I- Introduction
  • II- Requirements from the standard
  • III- Differences between IEC 62366:2008 and IEC 62366:2015
  • IV- Implementation of the requirements
  • V- Conclusion
  • VI- Assessment/test

Prerequisites

Participants should have a basic knowledge of:

  •  ISO 14971 and quality management systems and/or
  •  The medical device industry

What format does the training take?

MDSSPRO use interactive teaching techniques and keep the course varied and stimulating through exercises, working applications and case studies. Experienced and knowledgeable industry-leading tutors lead the course and ensure individuals stay engaged and that learning objectives are met.

The course can be run online or onsite at company offices.

MDSSPRO’s online training course is powered through a Performant Software platform. Online tutors are available throughout the length of the course and offer full support to course participants - answering questions, offering advice and explaining course material as required. 

Price

Online training course - £400 per person. We also offer this training at a special price for students, for more details contact us at admin@mdsspro.com. 

On-site training courses are customised to meet specific business requirements. Contact admin@mdsspro.com for costs and further information.
If you have any queries about our Usability Requirements course, please email
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