Netzealous LLC DBA - Compliance4All, Online
2017-10-30
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
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
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