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Applying Usability Principles to Drug Delivery Systems with IEC 62366-1:2020

Learn what it takes to meet usability requirements of IEC 62366, and understand how they relate to ISO 13485, ISO 14971, EU MDR, FDA, and ICH.

Whether you design the drug delivery system or contract with a medical device manufacturer, usability is key for your patients. It is important to understand how your users may interact with your drug delivery system to ensure the system functions properly and that all potential safety issues are understood. Human factors studies are part of the design process and should be integrated into risk analysis. This course provides an overview of the requirements of IEC 62366-1:2020, including the relationship with the risk management process
 
 
 
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Course Detail

What You Will Learn

At the end of this workshop, you will be able to: 

  • Describe the usability requirements in quality management system standards and regulations (IEC 62366-1:2020, ISO 13485:2016, ISO 14971:2019, EU MDR, FDA, and ICH)
  • Provide an analysis of the requirements of IEC 62366-1:2020
  • Illustrate the interactions between risk management and usability engineering
  • Practice documenting potential failure modes in usability and their effects
  • Describe the links between design usability, risk management, and complaints
  • Establish examples of traceability among user-related hazards, risk mitigations, product requirements, and verification/validation results
  • Determine procedures and evidence needed to demonstrate compliance to usability requirements in IEC 62366-1:2020 and related standards/regulations
  • Evaluate best practices in usability elements of premarket submissions

Who Should Attend

Anyone from the pharmaceutical and medical device industries involved in development, including regulatory personnel. Recommended for staff with the specific responsibility of risk management as well as quality engineering, technical services, operations, QA/QC, regulatory, and research and development.

  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.4

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

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Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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