Design Controls and Human Factors

12.0
RAC Credits
Virtual Programs
Tuesday, 19 October 2021 (9:00 AM) - Wednesday, 20 October 2021 (5:00 PM) Eastern Time (US & Canada)

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 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 fulfils regulatory expectations around safety and efficacy and simplifies use for end users. The following questions will be addressed:

  • How can manufacturers streamline the development process and ensure compliance to US and international standards?
  • What is the difference between formative and validation usability studies? What does each look like? Can design controls efforts be combined with human factors?

Pricing Amounts & Deadlines

16 November 2020 – 13 September 2021: Early Bird $750 Member | $850 Nonmember

14 September –18 October 2021: $800 Member | $900 Nonmember


Objectives

After this program, participants will be able to:

  • Identify the major design control elements and understand their contribution to the development of safe and effective medical devices.
  • Understand how Risk Management is incorporated throughout all human factors and product development processes.
  • 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 make decisions based on results from human factors studies and document them in the usability engineering file.

Agenda

Day 1 – Tuesday, 19 October 2021

  • Introduction
  • Design Controls Overview
  • Introduction to Human Factors
  • Risk
  • Risk Management and Human Factors
  • Planning
  • Planning for Human Factors
  • Design Inputs
  • Design Inputs and Human Factors
  • Interactive Exercise
  • Design Outputs
  • Design Output Requirements for Human Factors

Day 2 – Wednesday, 20 October 2021

  • Design Input – Human Factors
  • Interactive Exercise
  • Design Reviews and Inclusion of Human Factors
  • Design Verification and Formative Studies
  • Design Validation
  • Design Validation – Human Factors
  • Design Transfer 
  • [Design Changes
  • Design Changes
  • Interactive Exercise
  • Design History File
  • Postmarket Surveillance

Speakers

Margaret Koga Ward

Margaret Koga Ward has over 25 years of medical device experience, specializing in Product Development, Quality Management Systems, Internal and External Auditing, and Risk Management. She is currently an Independent Consultant, a Notified Body Auditor specializing in MDSAP and ISO 13485 audits, and an AAMI University faculty member. Her passion is helping companies achieve their quality system and product development milestones to advance their devices from concept through to commercialization within an FDA and ISO compliant quality system.

Bryant Foster

Bryant Foster is Co-founder and VP of Human Factors at Research Collective, a human factors and usability engineering consultancy in Phoenix, AZ, where he’s performed human factors and usability research for dozens of medical devices including surgical instruments, point-of-care devices, diagnostics, combination products, home-use devices, OTC products, and more. Bryant’s validation usability study protocols and reports are regularly approved by members of the human factors team at CDRH. He serves as an active member of the Human Factors Engineering committee within the Association for the Advancement of Medical Instrumentation (AAMI) and also teaches a Human Factors and Design Controls course for the Regulatory Affairs Professional Society (RAPS). Bryant’s also a member of the Healthcare and Product Design technical groups within the Human Factors and Ergonomics Society (HFES) and regularly speaks at both the annual HFES meeting and the HFES Healthcare Symposium. Bryant’s written numerous articles about human factors, usability, and human-centered design for several publications. Bryant holds a Master’s degree in human factors from Arizona State University.


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 to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org  

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