Please join us for a two day seminar titled “Is You 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.
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.
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.
DAY 1 : (8.30 AM – 4.30 PM)
- 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
- 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
- Continued discussion of “Guidance for the Content of Premarket Submission for Software”
- 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
- Developing a Risk Management File
- Develop a Risk Management DFMEA
- Develop an SHA
- Developing a Usability Strategy
- Develop an UFMEA
- Review & Summary
- Course Evaluations
DAY 2 : (8.30 AM – 4.30 PM)
- Questions from day 1 and scope for the day 2
- 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 requirements
- 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
- 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
- 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
- Processes, procedures, and outputs for typical phases (examples, roles, relationships)
- Defects and issues management
- Lessons learned from case studies and warning letters
- Documentation requirements for premarket submissions
- Review & Summary
- Course Final Evaluations
Principal and Founder, Software510K, LLC
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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- Please bring the respective passes to the event venue.
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DoubleTree by Hilton Boston Logan Airport
Boston, MA, USA | April 25 – 26, 2019