Medical Device Academy’s human factors training series includes our Usability Procedure (SYS-048), 11 videos, and related templates.
Human Factors Training Series ($950)
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Who needs training on human factors and usability engineering?
Most medical device manufacturers wait until they have already designed their medical device before they begin creating a usability engineering file. For experienced medical device manufacturers that are developing electrical medical equipment, creating the usability engineering file will begin a little earlier because they need this documentation for IEC 60601-1-6 certification. However, the human factors process needs to begin at the very beginning of your design project. Just like your risk management process, your human factors and usability engineering needs to occur in parallel with design and development. For example, your use specification identifies all of the user needs for your device that require design validation. Your team also needs to document formative testing that is conducted to evaluate various risk control options that you are considering
to prevent use errors. Therefore, anyone who is a member of your design and development team should have basic competency in area of human factors and usability engineering. That means you need to create a training plan for your entire design team.
When is the human factors training series available?
The human factors training series was recorded in 2024, and it includes 11 videos. Links to the training videos are provided as private YouTube videos, while the remainder of the contents is provided as a Dropbox link. You can share the content with other employees in your company (but not outside your company) and watch the training series as often as you wish.
What is included in the training series?
The human factors training series includes all eight of our training webinars on human factors and usability engineering. This includes all of the templates needed to create a usability engineering file (UEF) as required by IEC 62366 and the FDA. We are also including our usability engineering procedure (SYS-048) with this training series.
About Your Instructors
Matthew Walker – QMS, Risk Management, Usability Testing, Cybersecurity
Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Systems and Regulatory Pathways. He is a Junior in George Washington University’s BSHS- Clinical Research Management Program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.