The Impact of ALM Software on Your Medical Device Compliance
Featured Guest Speakers:
Griffin Jones, Consultant for context-driven software testing and regulatory compliance to companies in regulated and unregulated industries. Recently, he was the director of quality and regulatory compliance at iCardiac Technologies which provides core lab services for the pharmaceutical industry to evaluate the safety of their potential new drugs.
Jaimie Cole leads the Global Technology Center at iCardiac which consists of a team of talented and motivated technology professionals responsible for the COMPAS software platform, iClinica clinical trial management system, and IT infrastructure. Jaimie has also spent over 20 years in software development at Eastman Kodak, most notably on the Kodak Easyshare software team in Kodak’s Digital Camera division.
Facilitated by Regg Struyk, Product Manager, Polarion Software.
Please join us for this interactive, complimentary webinar with a panel discussion on how software is subject to regulatory software validation when used in the design of medical devices. Don’t miss this engaging panel discussion by leading medical device vendors like yourself.
What Regulations apply to software
Why is Traceability important
FDA’s General Principles of Software Validation 4.10 for off the shelf software
Should we adopt ALM software and when?
Risk based software validation
Please register to get immediate access to this on-demand webinar.