Our electrical safety testing webinar is part of our 510k course series to help you learn how to prepare an FDA eSTAR for powered devices.
Electrical Safety Testing Webinar ($79)
When is the Electrical Safety Testing Webinar?
This webinar will be live on Thursday, January 18, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as many times as you wish. If you already purchased our 510k course, you will automatically notified of the login information for this webinar via an AWeber email to subscribers of the 510k course. You will also be notified of future updates.
Why you should register for the Electrical Safety Testing Webinar
The testing requirements for 510k and De Novo submissions are based upon the most recently recognized standard for electrical safety. Still, the new FDA eSTAR asks the submitter to answer specific questions about the testing report and reference the pages where information can be found. In this electrical safety testing webinar, you will learn:
- how to prepare for electrical safety testing
- how to identify a testing lab
- when to engage a testing lab
- what documentation the testing lab will need
- what additional standards are applicable beyond IEC 60601-1
- how to determine what is considered essential performance
What you will receive
- a recording of the webinar you can replay anytime
- the native slide deck for this webinar
If you would like to ask specific questions about electrical safety testing, please submit them via email or schedule a call using the calendly app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the electrical safety testing webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
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 802.281.4381 or by email. You can also follow him on our YouTube channel, LinkedIn, or Twitter.