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.
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.
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