FDA's Guidance on Software and Device Changes and the 510(k)

Date : 15th April 2020 to 15th April 2020

Place : United States, Aurora

Website :http://bit.ly/3b7vQE9

Contact Person:Training Doyens

Description:

Know about the FDA guidance on medical devices 510k changes. The webinar covers how to manage software and device changes in an FDA compliant manner, FDA 510k submission checklist and more.

FDA's Guidance on Software and Device Changes and the 510(k) will be held in Aurora,United States on date 2020-04-15

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Deadline for abstracts/proposals : 15th April 2020

Keynote Speakers : Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

Conference Highlights :OVERVIEW The FDA has provided two guidance documents on software and device changes, which provide information as to whether a new 510(k) is needed. The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company’s decisions are provided. FDA provides a series of flowcharts and questions that can serve to g

Venue :Training Doyens, East Walker Drive, Aurora, CO, USA

Check the event website for more details.