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Engineering: Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

Health & care,Medicine, Biomedical science,medical devices,Engineering

NetZealous LLC

Summary

Price
£140 inc VAT
Or £46.67/mo. for 3 months...
Study method
Online
Duration
1 hour · Self-paced
Access to content
6 months
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
Additional info
  • Tutor is available to students

Overview

Human Factors/ Usability is the analysis of how people interact with medical devices.

The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.

Certificates

Certificate of completion

Digital certificate - Included

Description

Why you should Attend:

The FDA will only approve devices which are designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly. The FDA has replaced the term "user error" with "use error".

This means that use error is considered by the FDA to be a device nonconformity because human factors should be considered in the design process. The burden is on the device designer to create an "idiot proof" product.

Handouts are use specification template, user interface evaluation template, and usability validation control form.

Areas Covered in the Session:

  • User error versus use error
  • Use related hazards and risk analysis
  • User profiles
  • Use scenarios
  • Step by step human factors program development
  • validation

Who is this course for?

  • Engineer
  • Engineer Management
  • Quality Assurance
  • Regulatory

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Legal information

This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
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