Preparing a FDA 510(k) Submission

Live Webinar

  • 60 minutes

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.

In this webinar join expert speaker Edwin Waldbusser, where he will discuss contents and format for a Q-submission and 510(k) compliant with the FDA's, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a 510(k) submission in a least burdensome, effective manner.

Session Highlights:

  • 510(k) unique terminology

  • Refuse To Accept policy

  • What is a predicate device

  • Selecting a predicate device (substantial equivalence)

  • Where to find substantially equivalent predicate devices

  • How to handle software

Why You Should Attend:

Learn each step of the procedure and all the various types of submissions, as well as get clarity on the confusing concepts of predicate device and “substantial equivalence.” You will also learn how to find and acceptable predicate device and understand FDA’s requirements for medical device software.

Who Should Attend:

  • Regulatory affairs professionals
  • Engineering personnel
  • QA
  • Software developers
  • IT personnel
  • Management
  • Regulatory personnel 

  • R&D personnel

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Edwin Waldbusser

Edwin Waldbusser

Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems.  He has been a consultant for the last 9 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom,Netherlands, Canada, Poland and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, and supplier qualification/ control.

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.

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