- TypeWebinar
- Location New York, United States
- Date 25-04-2017
Education/Teaching/Training/Development
Medical/Healthcare/Hospital
Key Take Away :
This webinar will explain what the FDA 510(k) guidance is and the procedure to prepare the submission, the several types of 510(k), each part of the premarket notification – 510(k)submission including the very confusing concepts of predicate device and substantial equivalence.
Overview :
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 :
Learning Objectives :
Who Will Benefit :
Level:
Intermediate
Speakers Profile:
Edwin Waldbusser
Edwin Waldbusser 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.
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.
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