White Paper on The growing role of human factors and usability engineering for medical devices

This white paper is on “The growing role of human factors and usability engineering for medical devices”and is focused on “…applying knowledge of human capabilities and limitations Human Factors and Usability Engineering (HF/UE) contributes to the design of intuitive displays, controls, and other interfaces that substantially reduce the risk of user error.”  It is written by Bob North, Human Centered Strategies.

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series 

This is the last planned white paper in this series of white papers.  BSI said of the series that “…we are…producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The other white papers in the series you may be interested in reading, as they are very timely and current, are below:

• Negotiating the innovation and regulatory conundrum
• Engaging stakeholders in the home medical device market
• What you need to know about the FDA’s UDI system final rule
• Effective post-market surveillance; Understanding and conducting vigilance and post-market clinical follow-up
• The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market
• Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance

You can sign-up for future white papers or sign-up for their industry sectors newsletter.

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers or preparing for your Notified Body Audit, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

As you know Risk management is a necessary, yet onerous, task when developing electro-medical devices. Since IEC 60601-1 3rd ed. was published, manufacturers have faced many new risk management challenges with respect to their electro-medical devices, especially home health devices.

Avoid the common pitfalls of risk management in IEC 60601-1 3rd ed. Experts will share case studies in their risk management practices for their own devices.

Come join us at the RAPS Convergence Conference to learn more on this subject.

What’s it about:  The FDA published its draft guidance on Design Considerations for Devices Intended for Home Use in December of 2012, as part of an initiative started back in April 2010 “to support the safe use of medical devices in the home.” The guidance document is a significant step forward helping manufacturers understand the design criteria, user environments to consider, environmental considerations, and labeling issues. It also looks at other standards and FDA guidance manufacturers should consider, as well as post-market considerations, and other vital aspects of designing and developing devices that are intended to make the devices safer and easier to use.

Join us for this timely and informative audio conference presentation as our speaker takes attendees on a guided tour of the draft guidance. The presentation reviews the key points of the document as it relates to the IEC 60601-1-11 standard (Home Use Medical Electrical Equipment), human factors and usability (user environment), environmental considerations, labeling, and design controls (including risk management).

This audio conference will cover:

• Variations in the definition of home-use device under FDA and IEC 60601-1-11
• How the draft guidance relates to FDA’s Medical Device Home Use Initiative
• Environmental considerations discussed in the draft guidance
• User environments to be considered
• Key elements to keep in mind when designing home-use devices
• Labeling considerations
• Post-market considerations
• And more

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.