510k Submission Section 4: Indications for Use Webinar

The “Indications for Use” webinar is designed to help you prepare Section 4 of your next 510k submission. The webinar is presented by Rob Packard, President of Medical Device Academy.

The webinar covers the following training topics:

• Where to download the current FDA Form 3881
• Review of Indications Described in Regulations
• Review of Indications Described in Predicate 510k Summary
• More Broad Indications for Use
• More Narrow Indications for Use

This webinar is available for only $64.50– (INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):

Webinar: 510k Submission - Indications for Use

This webinar, presented by subject matter expert, Rob Packard of Medical Device Academy, provides detail related to preparing Section 4 of your 510k submissions on the topic of Indications for Use. Recording will be sent in a separate email.

Price: $64.50

10- Question Exam and Training Certificate available for $49.00:

Exam - 510(k) Section 4, Indications for Use

This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.

Price: $49.00

510(k) Medical Device Academy Training Overview – Brief Video

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.