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Healthcare Medical Software/Applications – Risks, Validation & Interoperability

January 31, 2013 @ 8:00 am - 1:00 pm

Course Description:

The complexity and expanding use of software outpaces what FDA and industry understand in a regulatory context. This leaves you and FDA at a loss for developing a practical regulatory program, especially one that can accommodate future designs and use. FDA’s publication of the final rule for the regulation of Medical Device Data Systems (MDDS) lays out criteria for the lowest level of software regulation. Future criteria remain fluid based on changing technology and its likely evolution. In the meantime, device firms need to establish a regulatory approach that can be adapted to future regulatory paradigms and FDA initiatives.

Software based medical device firms need to stay ahead of FDA’s regulatory approach, not catch up. You will learn how to enter and survive the world of the FDA’s regulatory reach. You will participate in an interactive learning experience with experts in FDA’s existing approach to software regulation and what you can see on the horizon. Attendees will learn how to understand their direct or indirect software based products in terms of current FDA requirements and policy. Armed with this information, a firm can develop an informed regulatory strategy.

Learning Objectives:

  • Understand FDA’s regulatory approach.
  • Identify software regulation criteria.
  • See the impact of software regulation.
  • Learn to manage software’s risk to health.
  • Learn Quality Systems manufacturing requirements.
  • Understand FDA’s initiative for regulating mobile applications.

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Details

Date:
January 31, 2013
Time:
8:00 am - 1:00 pm
Event Category: