Hazard Analysis following ISO 14971


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

Designing a medical device and testing it to prove that it works is not sufficient in the eyes of the FDA to provide a safe product for users. The FDA has determined, through analysis of product recall data that the majority of recalls were due to a faulty design process. These recalled products were tested before release and later found to fail in unanticipated ways that were not considered in the testing process. FDA also concluded that a well controlled design process with risk analysis, change control, design reviews and hardware/ software validation will greatly reduce the chances of an unsafe product.

Why should you attend this webinar?

This course will explain how to setup and manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. Such a program will also help to get projects completed on time and within budget.
The important question of when, in a development process, Design Control begins will be answered. The difference between pre release and post release change control will be explained. The Design History File will be explained and a contents checklist discussed.

Areas Covered in the Session:

Who can Benefit:



Webinar Id: LSHCEW001

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Duration: 60 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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