Is You Medical Device Software 510(k) Ready?

Date	Nov 15, 2018
Time	11:00 PM EDT
Cost	$1200.00
Online

One of the most common reasons that organization submitting a 510(k) for Software Enabled Medical Devices or Software as a Medical Device fail to obtain approval by the FDA is due to deficient or missing documentation. This Seminar will describe what is the FDA is expecting in the 510(k) submittal for software and how to make sure that the documentation meets those expectations to prevent costly time to market delays because of either initial denial or delays in the approval process.

Why You Should Attend:
With over 20 years of medical device software, system development, regulatory and management experience, our guest speaker, Nancy Knettell will share her experience of working with organizations submitting successfully for Regulatory Approval, their Medical Device Software whether it be standalone or Software enabled Medical Devices. Ms. Knettell has helped organizations submit successfully their Software rapidly and confidently as well as ensure follow up favorable audits with software are maximized.

Learning Objectives:

After completing this seminar, you will gain a better understanding of the expectations FDA have for your 510(k) submission for the Software Section of the submittal.

• Identify all of the pertinent and required Guidances that the FDA Recognizes in support of submitting a 510(k) for software
• Know what is required to have in place for Quality Systems to ensure your Software submission will be accepted for approval by the FDA for review to prevent costly time to market delays.
• Know exactly what software documentation needs to be prepared and how for a Class II/B/Moderate Level of Concern for the Software Portion to ensure.
• Know how to ensure the software documentation is prepared correctly specifically for the software portion of the submittal so that it will be in compliance preventing delays of the 510(k) approval.
• Avoid potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully.
• Know what is expected to have in place for compliance for your company during the preparation of a 510(k) to prevent this risk.
• Ensure a faster 510(k) approval because the documentation is complete and comprehensive.
• Prevent costly time to market issues because 510(k) has been rejected completely because of software.