You can register for this webinar about 510k boilerplate documents for free by just typing your name, email, and question in the form below.
510k Boilerplate Webinar
This webinar was recorded live on Tuesday, November 8, 2016. It’s free to register as long as you ask a question. As new questions are submitted I will create blogs to answer your questions and add the questions to our 510k FAQs page.
These requirements have changed since the FDA eSTAR was released.
Contents of 510k Boilerplate webinar
The webinar recording explains how to complete three templates for a 510k submission. Specifically, the presentation explains how to complete the following sections:
- Section 3 – Confidentiality Statement (not required)
- Section 6 – Truthful & Accuracy Statement (required, but option automatic generation by eSTAR)
Section 7 – Class III Summary and Certification (no longer applicable to eSTAR)- Section 8 – Financial Certification and Disclosure Statement (FDA Forms 3454, 3455, and 3674)
In addition to receiving access to the live webinar, you will receive the native slide deck and the three templates for these three sections. Registrants will also receive a link to download a recording of the webinar and additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page.
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 Google+, LinkedIn, or Twitter.