Medical Device Academy’s De Novo webinar bundle includes 6 videos, and related templates all to streamline your process. Your cart is empty
De Novo Webinar Bundle
De Novo Webinar Bundle ($599)
De Novo Webinar Bundle
Get everything you need to confidently prepare your De Novo submission with this comprehensive bundle. This package includes essential tools and guidance to help streamline your process and meet FDA expectations.Price: $599.00
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After verifying the transaction, please check your email for the download (including your spam folder).
What is included in the webinar bundle?
The De Novo webinar bundle includes all six of our training webinars related to De Novo submissions from our 510k course series. This includes all of the templates needed to complete a De Novo submission.
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 +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.