When: |
30 Oct through 30 Oct 2017 | |
CFP Deadline: |
30 |
|
Where: |
Fremont, United States | |
Website URL: |
http://www.compliance4all.com/control/w_product/~product_id=501507LIVE?channel=brownwalker_Oct_2017_SEO | |
Sponsoring organization: |
Netzealous LLC DBA - Compliance4All | |
Categories: |
Education / Legal / Other - Education |
Keywords:
Event description:
Overview:
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.
Why should you Attend:
Anyone who is involved in software and device design, modification, manufacturing, quality testing and distribution should be aware of these changes and the impact on decision-making as to whether or not to prepare a new 510(k). The FDA provides flowcharts that guide the reader to the best decision, but some judgment is also required.
Areas Covered in the Session:
Medical Device changes
Software Application changes for software used in conjunction with medical devices
FDA Guidance Documents
FDA Enforcement
New 510(k) submission
Who Will Benefit:
Information Technology (IT) Analysts
IT Developers
IT Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Speaker Profile:
Carolyn (McKillop) Troiano Carol...
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Posting date:
24 August 2017 | 135 views
Placement:
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