Medical Device Academy is a full-service QA/RA consulting firm for medical devices. Our goal is to help startup companies get their first device to market. We know you have a limited budget, so we post free training videos on this channel in addition to our paid webinars. On our website, we have a complete turnkey quality system for sale: medicaldeviceacademy.com/. We have dozens of clients from other countries that we are helping to obtain 510(k) clearance and to implement a quality system compliant with ISO 13485:2016 and applicable national regulations. We now offer FDA US Agent services at: fda-us-agent.com/. Live-streaming videos are hosted on this channel every Friday at 12:30 pm Eastern. If you have a topic you want us to talk about, please leave a comment under our discussion tab. Please don't forget to share videos with colleagues you think would benefit from our content.
Medical Device Academy
The FDA released new inspection guidance last week.
4 months ago | [YT] | 0
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Medical Device Academy
Just a reminder...our weekly live-streaming videos are now on Thursday @ 12:30 pm ET
5 months ago | [YT] | 1
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Medical Device Academy
I had to jump at this opportunity. I'm going to Carlsbad, CA to train with Leo Eisner. If you can spare the time, register here: www.nemko.com/2026-medical-device-compliance-certi… - This is the link for registration with Nemko. I'm looking forward to meeting you on February 2nd.
6 months ago | [YT] | 0
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Medical Device Academy
With 150 house fires annually in the US attributed to a Christmas tree fire, understanding proper fire safety is paramount, especially during the holidays.
Medical Device Academy will be discussing use errors this Friday in a live video with Rob Packard and Matthew Walker--our resident usability consultant and firefighter.
Our live-streaming video will explore how to identify simple use errors and evaluate the potential harm of those use errors. Join us for valuable safety training and practical tips where you will learn a little about usability engineering.
We are going to do this in a fun way by using a tier ranking chart to score the potential harm of each use error.
We also thought this would be a fun exercise to help teach usability engineers how to rank harm when they are analyzing use-related risks.
What if the biggest risk to your users isn’t the harm itself…but the way your team evaluates it?
When it comes to usability testing, teams rarely struggle with identifying use errors—but they make critical mistakes when ranking the harms associated with those errors. Making a mistake in ranking harms can derail your entire risk analysis.
If you rank a harm too low, then you might not implement adequate controls to reduce use-related risks. If you rank a harm too high, you might do more usability testing than is necessary.
In our live-streaming video, we provide a list of use errors and rank each error by the severity of harm in a tier ranking system. As our case study example, we will be discussing use errors that might occur when decorating a Christmas Tree.
Happy Holidays!
📌 This is our last live-streaming video for 2025. Our next live-streaming video will be:
🗓️ Thursday, January 15, 2026, @ 12:30 p.m. ET
We are switching to Thursdays for 2026 instead of Fridays. Don’t forget to join us each Thursday for our live-streaming videos in 2026.
6 months ago | [YT] | 0
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Medical Device Academy
I have had this exact conversation with so many clients. Everyone hates the "it depends" answer, but the explanation is clear. I especially liked the image of the 2-part testing: 1) package integrity testing, and 2) device performance testing. It doesn't matter what device we are talking about, everyone needs to answer these questions and do their risk analysis.
7 months ago | [YT] | 0
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Medical Device Academy
Pre-orders for the 2026 lead auditor course begin on Cyber Monday. You can save $700 by purchasing before December 19, 2025, @ 5 p.m. ET. This video will answer all your questions.
7 months ago | [YT] | 1
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Medical Device Academy
If you missed our Friday live-streaming video, it is available on our YouTube channel as a recording.
7 months ago | [YT] | 2
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Medical Device Academy
Don't miss this live-streaming video on Friday @ 12:30 pm ET.
7 months ago | [YT] | 0
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Medical Device Academy
“Why do I need to do all the design controls if the FDA only asks for the test report?”
It’s a question we hear from medtech founders all the time — and Kelly Kucharczyk brought it up during our conversation at Project Medtech’s Startup Symposium in Philadelphia, 2025.
Rob Packard explains why documenting as you go (instead of retrofitting it a year later) saves startups enormous time and stress when preparing a 510(k).
Here’s the 60-second highlight 👇
The full interview drops later this week — follow us to catch the complete discussion.
7 months ago | [YT] | 0
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Medical Device Academy
Master data collection & report delivery — LIVE this Friday!
Whether you’re an auditor, biomedical engineer, or student, learn how to go from raw data to a polished report that impresses.
What you’ll learn:
• Using templates for consistent structure
• Photo/data form best practices
• Screen-capture workflows & copy-paste accuracy
• Hands-free AI transcription
• Our favorite online tools for seamless teamwork
Why watch? 35+ years of tips that save hours on every report.
7 months ago | [YT] | 0
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