This webinar explains interoperability testing requirements for medical devices that receive or transfer information to other devices.
Interoperability Testing Webinar ($79)
This webinar was specifically created for medical device companies preparing an FDA submission using the latest version of the FDA eSTAR. The FDA eSTAR requires that you provide testing data for any electronic interfaces in your medical device system. In this webinar, we will explain how to complete our interoperability testing template along with a copy of the template.
Please note: These products will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
When is the Interoperability Testing Webinar?
This webinar is scheduled for August 21, 2024 @ 10:30 a.m. ET. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your FDA eSTAR submission, we offer a standard fee for 510k submissions or we can help you on an hourly basis.
What you will receive in the Interoperability Testing Webinar:
- Interoperability Testing Template
- Login information to live webinar (if purchased on or before August 21, 2024)
- Recording of live webinar
- Native PowerPoint Slide Deck
If you would like to upgrade your purchase to our entire 510k Course, which includes templates and webinars for pre-submissions, 513(g) Classification Requests, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of this webinar.
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 510k submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.