On-demand Webinar:

The Impact of ALM Software on Your Medical Device Compliance

Featured Guest Speakers:

griffin_jones

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

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.

regg_struyk

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.

Agenda Topics:

  • 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
  • Interactive Q&A

Please register to get immediate access to this on-demand webinar.