Most
medical device and pharmaceutical companies know they need to make their
products as usable as possible, but many have difficulty understanding how to
design their product with usability in mind from the ground up.
This
interactive workshop is designed to take participants through the design
control elements, emphasizing how human factors fit into each step in the
design process.
The
workshop addresses the steps necessary to develop a truly usable product that
fulfils regulatory expectations around safety and efficacy and simplifies use
for end users.
Pricing Amounts & Deadlines
5 Oct – 30 Oct 2020:
Regular $750 Member | $850 Nonmember
OBJECTIVE
- Identify
the major design control elements and understand their contribution to the development
of safe and effective medical devices.
- Understand
how human factors fit into product development and design controls.
- Outline
and describe the costs associated with human factors studies.
- Develop
strategies for identifying device users, user environments and critical tasks.
- Identify
methodological differences between generative, formative, and
validation/summative studies.
- Be able
to make decisions based on results from human factors studies and document them
in the usability engineering file.
WHO SHOULD ATTEND?
- Recently, there have been significant changes in the
requirements around human factors for medical devices. This workshop will
provide practical guidance and information for:
- Regulatory affairs professionals
- Quality assurance managers and engineers
- Product development and design engineers
- Human factors and usability engineers
- Program and project managers
AGENDA
DAY 1
•
Introduction to Design Controls
•
Introduction to human factors as it relates to
safety in medical device design
•
Risk Management requirements for medical device
development
•
Preliminary analysis of users, environments, and
use-related risk
•
Design and Development Planning
•
Creation of a human factors strategy
•
Design Inputs
DAY 2
•
Design Inputs for human factors
•
Design outputs and the role of human factors
•
Formative human factors studies
•
Design Reviews
•
Design verification
DAY 3
•
Design validation
•
Validation / Summative usability studies
•
Design transfer
•
Design Changes
•
Strategies for writing successful human factors
and usability engineering reports
•
Design history file / design and development
file
•
Post market surveillance and the EU MDR
SPEAKERS
Bryant
Foster, vice president, human factors and user experience, Research Collective
Margaret Koga
Ward, principal engineer and owner, Teragram, LLC
CANCELLATION POLICY
RAPS reserves the right to cancel this program at its sole
discretion. RAPS will not be responsible for travel or other costs incurred due
to cancellation.
All cancellation requests must be submitted in writing via
our online cancellation form. RAPS is unable to accept cancellations by phone.
Please specify the name of the person registered and event title.
Substitutions may be accepted with written approval from
RAPS and must be submitted to raps@raps.org.
PROOF OF ATTENDANCE
RAPS will send an electronic letter or a certificate of
attendance upon request.
QUESTIONS
Call RAPS Solutions Center at +1 301.770.2920, Ext 200