Animal Studies and Human Clinical Studies for 510k Submissions

In this webinar you will learn how to create a summary for the Animal Studies and Human Clinical Studies sections of your 510k submission.

Why you should register for the Animal Studies & Human Clinical Studies Webinar

In this webinar you will learn exactly how to prepare the Animal Studies and Human Clinical Studies sections of your submission. FDA guidance documents regarding both types of studies are also included.

What you will receive for $79

  • a recording of the webinar you can replay anytime
  • the native slide deck for this webinar

There are 22 slides in this presentation. The is 38 minutes in duration.

Q&A

Please submit questions to me by email at rob@13485cert.com regarding the Animal Studies & Human Clinical Studies Webinar. If you have company-specific questions, please send me a request to set-up a private call to discuss your specific issues.

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Animal Studies & Human Clinical Studies Webinar $79

Animal Performance Testing 150x150 Animal Studies and Human Clinical Studies for 510k Submissions
Animal and Human Clinical Studies

In this webinar you will learn how to create a summary for the Animal Studies and Human Clinical Studies sections of your 510k submission.

Price: $79.00

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About Your Instructor

Rob 150x150 Animal Studies and Human Clinical Studies for 510k Submissions

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.

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