Netzealous LLC DBA - Compliance4All, Online
2018-10-12
Overview: A 510(k) is a premarket submission made to FDA to demonstrate that the
device to be marketed is at least as safe and effective, that is,
substantially equivalent, to a legally marketed device (21 CFR 807.92(a)
(3)) that is not subject to PMA.
Why should you Attend: This includes any major change or modification to the intended use of the
device that could have an impact on patient safety and effectiveness. After
attending this webinar, you will be able to better navigate the processes
required to determine how to manage software and device changes in an
FDA-compliant manner.
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 Substantial Equivalence
Who Will Benefit: Information Technology (IT) Analysts IT Developers IT Support Staff QC/QA Managers and Analysts Clinical Data Managers and Scientists Analytical Chemists Quality Managers, Chemists and Microbiologists Compliance Managers and Auditors Lab Managers and Analysts
Event Fee: One Dial-in One Attendee Price: US $290.00
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
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