Live Webinar on Human Factors/ Usability Studies Following ISO 62366 and the New FDA Guidance


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 medical device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors/usability analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDAGuidance document.
WHY SHOULD YOU ATTEND
The FDA will only approve devices which are so designed 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 device nonconformity because human factors/ usability should be considered in the design process. The burden is on the device designer to follow usability studies, perform medical device risk analysis and create an “idiot proof” product.
Handouts are use specification template, user interface evaluation template, and usability validation control form
AREAS COVERED
  • Difference between user error and use error 
  • Use related hazards and risk analysis
  • User profiles
  • Use scenarios
  • Step by step human factors program development
  • validation
LEARNING OBJECTIVES
Learn about use related hazards and risk analysis in medical devices and how to create a device that complies with the FDA guidance. Know how to assess human factors/usability in the design process and maintain compliance with ISO 62366.
WHO WILL BENEFIT
  • Engineer
  • Engineer management
  • Quality assurance
  • regulatory


For more detail please click on this below link:
https://bit.ly/2sMbHzm

Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882




Comments

Post a Comment

Popular posts from this blog

Small Business Management Made Simple:Tools, Tips & Techniques for Successful Business Management

Image
OVERVIEW Many business owners and managers have excellent product ideasthat could be very profitable.   However, their enterprises are not as successful as they could or should be.  This is typically due to their lack of a basic understanding and foundation of the tools and techniques needed to successfully manage a business.  This webinar is a summary of simple tools and techniques needed to be successful at managing a business. It also offers helpful hints and bits of wisdom included in thespeaker’s published handbook – Small Business Management Made Simple! This handbook is based on his 30 years of business management, ownership and business coaching experience. How To Start Own Business WHY SHOULD YOU ATTEND The handbook and webinar were developed with the business owner/manager in mind.  It covers all the significant items needed to succeed in business, based primarily on personal experiences and knowledge acquired in the actual management of various business ente
Read more

SharePoint Site Owner – Setting Up and Managing Your SharePoint Site

Image
OVERVIEW Microsoft Office SharePoint  has become the standard way for companies and organizations to share relevant info and files with other people in the company and with people outside of the company as well. In this webinar, you will learn how to set up a  SharePoint  site and manage it well. how to set up a sharepoint site WHY SHOULD YOU ATTEND So, your company has switched over to Microsoft Office SharePoint. Maybe some people in your company have set up their own sites. And then, your boss tells you that you are going to be in charge of your department’s SharePoint site. What do you do? Where do you even start? This webinar will show you how to set up a SharePoint site and manage it as well. If you are in charge of Microsoft Office SharePoint or SharePoint site permissions, or if you are going to be, you need this SharePoint administration training. AREAS COVERED Microsoft SharePoint overview Screen tour Adding logos and colors to your site Adding u
Read more

Coronavirus Risks and Opportunities - Ensuring Safe Business Operations in Compliance with the Updated Laws

Image
  OVERVIEW This webinar will provide an overview of measures that businesses can take to reduce their vulnerability to further disruption by COVID-19 and similar illnesses while they protect workers and other stakeholders such as customers, and also contribute to public health by "flattening the curve." The good news is that there is a wide array of proven off-the-shelf countermeasures such as social distancing, workplace controls, and face masks that impede the spread of contagious diseases. OSHA has already released authoritative guidance that is likely to be embodied in a formal standard later this year, but proactive organizations can have most of the requirements in place before they become mandatory. Many jobs can be performed remotely which eliminates the risk of contagion completely, and also reduces costs of a physical presence such as office or classroom space, and commuting and lodging costs. Organizations must also reassess supply chain vulnerabilities to forc
Read more