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2018 - FDA New Draft Guidance on (Software) and Device Changes 510k



VenueFremont, USA - United States USA - United States

KeywordsAutomation Analysts; Regulatory Affairs; Business Stakeholders


Topics/Call fo Papers

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
Speaker Profile:
Carolyn (McKillop) Troiano has more than 35 years of experience in the
tobacco, pharmaceutical, medical device and other FDA-regulated
industries. She has worked directly, or on a consulting basis, for many of
the larger pharmaceutical and tobacco companies in the US and Europe,
developing and executing compliance strategies and programs. Carolyn is
currently active in the Association of Information Technology Professionals
(AITP), and Project Management Institute (PMI) chapters in the Richmond,
VA area.
Event Fee: One Dial-in One Attendee Price: US $290.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Last modified: 2018-08-10 14:34:12