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 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. These same requirements also apply to software as a medical device (SaMD).
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 “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.
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 about the 510k Hardware and Software Documentation Webinar
Please submit questions to me by email at email@example.com regarding the 510k Hardware and Software Documentation Webinar.
510k Hardware and Software Documentation Webinar available for $129.00
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.