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MEDICAL SPECIALTIES ...

Guidance on Software and Device Changes and the 510(k)

From Monday, October, 30, 2017 to Monday, October, 30, 2017 in CA
Starting from:10:00
Concerned sectors: Biotechnology -
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 Carolyn 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
PUBLIC, SECTORS, ACCREDITATION
Accreditations: 0
Concerned Public:
Attendance: International
Visitors/Participants: 100
Speakers: 1
Exhibitor: n.c
Event Type: Online Conference
Major Sector: BIOTECHNOLOGY
Concerned sectors: Biotechnology -
ORGANIZER / ADVERTISER

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congress, conferences or medical training REF #28-7588
Guidance on Software and Device Changes and the 510(k)
Published on congres-medical.com on:2017-10-12 11:42:57
Congress, conferences or medical training in BIOTECHNOLOGY
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