Design Controls and Human Factors

When:  Aug 28, 2019 from 9:00 AM to 4:00 PM (ET)

Design Controls and Human Factors 
Regulatory professionals are responsible for implementing design control procedures into the development of medical devices. Most medical device and pharmaceutical companies know they need to make their products as usable as possible, but many have difficulty understanding with how to design their product with usability in mind from the ground up. Often, regulatory affairs professionals are relied upon to educate development teams about the need to establish design controls and incorporate human factors early in development. This interactive workshop is designed to take participants through the design control elements, emphasizing how human factors fits into each step in the design process. This workshop addresses the steps necessary to develop a truly usable product that fulfills regulatory expectations around safety and efficacy and simplifies use for end users.

Program Dates: 
28-29 August 2019 
Registration Closes:  21 August 2019
Refund Deadline:  29 July 2019 

RAC Credits: 
12 (Upon attending and completing the program)

Will the meeting be recorded?  No

Registration to 29 July  
RAPS Members:  $1050
Nonmembers:  $1150

Registration from 30 July to 21 August 2019
RAPS Members:  $1150
Nonmembers:  $1250

NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted. 

Program Outline

Design Controls
1) Introduction to design controls
2) Design and development planning – input, output, review, verification, validation, transfer, changes and design history files (DHF). 

Human factors
1) Introduction to human factors as it relates to medical device design
2) Description of the human factors process
3) Human factors preliminary analyses
4) Creation of a human factors strategy
5) Formative human factors studies
6) Validation usability studies
7) Characteristics of a human factors report

The agenda may vary based on changing requirements.

Costa Mesa Marriott
500 Anton Blvd. 
Costa Mesa, CA 92626

Bryant Foster, vice president, human factors and user experience, Research Collective
Margaret Koga Ward, principal engineer and owner, Teragram, LLC

Program Objectives - a
t the conclusion of this workshop, participants should:
Understand how human factors fits into product development and design controls
Outline and describe the costs associated with human factors studies
Develop strategies for identifying device users, use environments and critical tasks
Identify methodological differences between generative, formative, and validation/summative studies
Be able to write up positive and negative results from human factors studies

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 to attendees on what they need to know so that they can prepare for a successful human factors validation study. This workshop will help participants understand the human factors requirements, how to make sure the device design meets those requirements, and how the human factors portion of the submission should be written. By the conclusion of this workshop, students will know their regulatory submissions need to contain related to human factors.

All requests for cancellation must be received in writing or by calling customer service. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment if received by 29 July unless otherwise specified. Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to Substitutions may be accepted with written approval from RAPS and should be submitted by 14 August.

Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance upon request.

Call RAPS Solutions Center at +1 301.770.2920, Ext 200

Other Information
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.

Registration Form 
If it is your preference, please use the Registration Form to register by mail, email or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer.

Program Contact
Nichelle Sankey
+1 301 770 2920, Ext 291

Area Hotels
Costa Mesa Marriott (workshop venue)
500 Anton Blvd. 
Costa Mesa, CA 92626
(714) 757-1100

Avenue of the Arts Costa Mesa, A Tribute Portfolio Hotel 
3350 Avenue of the Arts 
Costa Mesa, CA 92626
(714) 751-5100

The Westin South Coast Plaza Costa Mesa
686 Anton Blvd. 
Costa Mesa, CA 92626
(714) 540-2500


500 Anton Blvd
Costa Mesa, CA 92626-1911