Usability and Human factor training course
This 1 day training course 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 and MDD compliance and explains how businesses can guarantee safety claims of medical devices.
Learning objectives / course outcomes
By the end of the course, participants will be able to:
Identify the links between MDD/ 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
II- Requirements from the standard
III- Differences between IEC 62366:2008 and IEC 62366:2015
IV- Implementation of the requirements
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 uses interactive teaching techniques, keeping the course varied and stimulating through exercises, working applications and case studies. Experienced and knowledgeable industry-leading tutors ensure individuals stay engaged throughout the course and that the 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 offering full support to course participants, answering questions, offering advice and explaining course material as required.
Online training course - £400 per person.
On-site training courses are customised to meet specific business requirements. Contact for costs and further information.