Is your Medical Device Software 510(k) Ready?: 2-Day In-Person Seminar

By: Nancy Knettell, Principal and Founder, Software510K, LLC
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Course Description:

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.

Please join us for a two day seminar titled “Is Your Medical Device Software 510(k) Ready?” to learn This course will ensure that Device companies will know exactly what documentation needs to be prepared. They will also know how to ensure the documentation is prepared correctly specifically for the software portion of the submittal so that it will be in compliance and will prevent costly delays of the 510K approval by the FDA.

Companies can also face potential audit risks and serious findings post submittal that can block their ability to ultimately sell their product successfully. This course will ensure that you know what is expected to have in place for compliance for your company during the preparation of a 510K to prevent this risk as well.

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.

This two day seminar will be jammed packed with numerous lessons learned, case studies, and specific directions that showcase what is required for a faster and successful 510(k) submission for your Medical Device Software.

By implementing the ideology, tools and techniques that will be discussed in this two-day seminar will surely help “Instill the Value of Safety” within your workforce.

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.

Areas Covered:

The areas that will be discussed in the seminar will include the following topics throughout the agenda:

  • The key components of ensuring the Software part of your submittal is not rejected.
  • What constitutes Compliance prior to the Submittal.
  • Leading barriers in your organization for .
  • Software development life cycle (SDLC)
  • Verification and validation, including regulatory definitions, regulatory intent, and common tasks
  • Key regulations, standards, and guidance documents
  • Integrating risk management processes in your submittal
  • Design control and software validation guidance
  • Testing level strategies (unit, integration, system, user)
  • Methods development and documentation requirements
  • Test protocol content
  • Documentation requirements for premarket submissions
  • Processes, procedures, and outputs for typical phases (examples, roles, relationships)
  • Design and quality planning, including traceability and reviews
  • Lessons learned from case studies and warning letters

Who will benefit:

  • Medical Device Software Regulatory professionals
  • Medical Device Software Quality Assurance Engineers
  • Medical Device Software Quality Senior Management
  • Medical Device Software Company Senior Management
  • Medical Device Quality Engineers
  • Medical Device Quality Senior Management
  • Medical Device Software Engineering Manager
  • Medical Device Software Engineers
  • Medical Device Software R+D Managers
  • Medical Device Software Company CEOs
  • Medical Device Software VP Engineering

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 8:30 - 8:59 Registration Meet & Greet.
  • 9:00 - 10:30 Introductions: Seminar objectives review, expectations and scope.
  • 9:00 -10:00
    • Seminar objectives review, expectations and scope.
    • What are the main challenges that cause Companies to fail to meet the 510(k) standard for Software
    • Do you have a complete Software Package or a Prototype and what is the difference.
  • 10:00-11:00
    • Introduction of the Main Guidances that the FDA recognizes as meeting the Standard for Medical Device Software Development and impact the 510(k) filing.
    • Discussion on how they fit together
    • Introduction to “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”
    • Discussion of Device Class vs. Level of Concern Determine Level of Concern
  • 11:00-12:00
    • Continued discussion of “Guidance for the Content of Premarket Submission for Software”
  • 12:00-1:00 Lunch
  • 1:00-2:00
    • Continued discussion of Submission Requirements for Guidance for the Content of Premarket Submission for Software” Was is actually ends up being required vs. What the document states.
    • Introduction to ISO14971 Risk Management at the System and Software Level
  • 2:00 – 3:00
    • Developing a Risk Management File
    • Develop a Risk Management DFMEA
    • Develop an SHA
  • 3:00-4:00
    • Developing a Usability Strategy.
    • Develop an UFMEA
  • 4:00-4:30
    • Review & Summary.
    • Course Evaluations.
Day Two (8:30 AM – 4:30 PM)
  • 8:30-8:59 Meet & Greet.
  • 9:00 -10:00
    • Questions from Day before
    • Introduction to IEC62304 and exactly what is required for Compliance and the submittal process and to ensure a successful submittal.
    • Describe how organizational responsibilities and interactions can affect the SDLC and the ability to meet regulatory re-quirements
  • 10:00-11:00
    • Identify the typical phases, processes, and deliverables of a software development life cycle (SDLC).
    • Map these phases, processes, and deliverables to US and global regulatory requirements and standards, including IEC 62304 and its addendum.
  • 11:00-12:00
    • Verification and validation, including regulatory definitions, regulatory intent, and common tasks
    • Testing level strategies (Unit, Integration, Verification, System)
    • Design and quality planning, including traceability and reviews.
  • 12:00-1:00 Lunch
  • 1:00-2:00
    • Identify requirements for validating nonproduct software (quality management system software), using the guidance of AAMI TIR36
    • CyberSecurity and how it fits into the Design/Development Process.
  • 2:00-3:00
    • Processes, procedures, and outputs for typical phases (examples, roles, relationships)
    • Defects and issues management.
  • 3:00-4:00
    • Lessons learned from case studies and warning letters.
    • Documentation requirements for premarket submissions
  • 4:00-4:30
    • Review & Summary.
    • Course Evaluations.
    • Adjourn.

Meet Your Instructor

Nancy Knettell
Nancy Knettell
Principal and Founder, Software510K, LLC

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined mechanical design, software development, and systems engineering experience primarily in the medical device industry as a Software Verification, Validation/Systems Engineer.

Along with her senior level management experience with cross-functional program teams for major companies such as EMC and United Technologies, Nancy has also consulted to major medical companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Applied Biosystems, Deka Research, Avedro and Hologic.

But, for Nancy, involvement in medical device development is a personal issue. Having lost her father at an early age to heart disease, she now wants to work to help other people facing such life threatening events. It is her mission to advance the potential for life-saving medical devices through the use of quality based engineering systems.

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