In this 510k hardware and software documentation webinar you will learn what documents are expected in sections 16 and 17 of a 510k submission.
510k Software Documentation
Section 16 is specific to software documentation, and there are 12 documents that I recommend including for a 510k submission that includes software–including firmware. In many of the recent submissions I have prepared, the software section has not been ready at the beginning of the project and the manufacturers have not had adequate software quality systems in place during the software development. In this webinar I will provide a brief overview of the the various documents and provide links to both the FDA software guidance and a free webinar on 510k software documentation. I will also review the recognized standards that should be included in your submission of a 510k and how to complete FDA Form 3654 for these standards.
510k Hardware Documentation
Section 17 is specific to electrical safety and electromagnetic compatibility testing documentation. There is a new guidance document from the FDA regarding EMC testing data that will be reviewed during the webinar. I will also provide a brief overview of the the “home use” guidance document, and provide links to both of the FDA guidance. Finally, I will also review the recognized standards that should be included in your submission of a 510k and how to complete FDA Form 3654 for these standards.
Webinar Details?
This webinar was recorded live on Friday, August 12. Anyone purchasing this webinar will receive a recording of the webinar and a copy of the native slide deck for $129. The presentation slide deck includes 27 slides during the presentation. The presentation is slightly longer than an hour–including the Q&A session.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the 510k Hardware and Software Documentation Webinar.
510k Hardware and Software Documentation Webinar available for $129.00
In this 510k hardware and software documentation webinar you will learn what documents are expected in sections 16 and 17 of a 510k submission. This live webinar will be 50-60 minutes in length. You will receive access to the live recording and the native slide deck.
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About Your Instructor
Rob Packard is a regulatory consultant with ~25 years 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 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 certification. From 2009-2012, 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 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.
