How to Prepare a FDA 510(k) submission


Ed is Keynote Speaker at Compliance key Inc. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanic........

Overview

we will explain what a 510(k) is and the procedure to prepare the submission. the several types of 510(k) will be explained.Each part of the submission will be explained. The very confusing concepts of predicate device and substantial equivalence will be discussed. How to find an acceptable predicate device will be taught. FDA places special emphasis on device software. we will cover the requirements for software.

Why should you attend this webinar?

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 the Session:

Who can Benefit:



Webinar Id: LSHCEW002

Training Options:

Duration: 60 mins

 Recorded: [Six month unlimited access]

 $237(Single Attendee)  $599(Unlimited Attendee)

Refund Policy
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