|Date:||April 25, 2017 - 1:00pm - 2:00pm|
|Timezone:||(GMT-05:00) Eastern Time (US & Canada)|
|Location:||AtoZ Compliance ,2754 80th Avenue, New Hyde Park, NY, 11040, United States|
|Website for Event:||https://www.atozcompliance.com/trainings-webinar/life-sciences/medical-devices/f...|
Key Take Away :
Understand FDA 510(k) process for medical devices. How to find an acceptable predicate device will be taught. FDA places special emphasis on device software. We will cover the FDA regulations for medical devices software.
Why Should You Attend :
Preparing a submission to get FDA approval for a new product is time consuming and confusing. The submission requirements refer to many unfamiliar concepts and terms such as predicate device and substantial equivalence. More than half of all submissions are rejected. We will teach you to prepare a submission meeting all the FDA requirements.
Areas Covered In This Webinar :
510(k) unique terminology
Learning Objectives :
Learn how to submit a FDA 510(k) application
Who Will Benefit :
Regulatory affairs (associates, specialists, managers, directors or VPs)
For more information, please visit : https://www.atozcompliance.com/trainings-webinar/life-sciences/medical-d...
His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.
Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
|Contact Name:||AtoZ Compliance|