Instructor :
Carolyn Troiano

Webinar ID:
12535

Gain a comprehensive understanding of the FDA’s new draft guidance on 510(k) compliance for medical device and software modifications.

This 90-minute course equips medical device manufacturers with the latest strategies to determine when a new 510(k) submission is required, minimizing compliance risks and enhancing regulatory clarity.

Key Takeaways:

• • Guidance on Device Modifications: Learn the FDA’s criteria for assessing whether device changes require a 510(k). The course covers key aspects like labeling, technology and engineering updates, performance adjustments, and materials. Special focus on in vitro diagnostic devices is included.
  • Step-by-Step Flowcharts: Explore the FDA’s series of flowcharts and decision trees designed to guide manufacturers in evaluating necessary updates, with practical examples to streamline your internal compliance decisions.
  • Software Update Compliance: Understand the latest FDA guidance on software modifications related to medical devices. The course breaks down the essentials of compliance for corrective updates, patches, and functional enhancements, helping you assess any potential impact on device safety and effectiveness.
  • Risk Assessment Best Practices: Discover how to implement a risk assessment for device and software updates, following the FDA’s structured approach. The course includes examples and insights on determining whether a change impacts 510(k) compliance.

By the end of this training, participants will be able to accurately evaluate device and software updates, make informed compliance decisions, and document the process effectively, all while aligning with the latest FDA guidelines for 510(k) submissions.

Enroll Now!

Gain a comprehensive understanding of the FDA’s new draft guidance on 510(k) compliance for medical device and software modifications.

This 90-minute course equips medical device manufacturers with the latest strategies to determine when a new 510(k) submission is required, minimizing compliance risks and enhancing regulatory clarity.

Key Takeaways:

• • Guidance on Device Modifications: Learn the FDA’s criteria for assessing whether device changes require a 510(k). The course covers key aspects like labeling, technology and engineering updates, performance adjustments, and materials. Special focus on in vitro diagnostic devices is included.
  • Step-by-Step Flowcharts: Explore the FDA’s series of flowcharts and decision trees designed to guide manufacturers in evaluating necessary updates, with practical examples to streamline your internal compliance decisions.
  • Software Update Compliance: Understand the latest FDA guidance on software modifications related to medical devices. The course breaks down the essentials of compliance for corrective updates, patches, and functional enhancements, helping you assess any potential impact on device safety and effectiveness.
  • Risk Assessment Best Practices: Discover how to implement a risk assessment for device and software updates, following the FDA’s structured approach. The course includes examples and insights on determining whether a change impacts 510(k) compliance.

By the end of this training, participants will be able to accurately evaluate device and software updates, make informed compliance decisions, and document the process effectively, all while aligning with the latest FDA guidelines for 510(k) submissions.

Enroll Now!

Navigating FDA compliance for device and software changes is becoming increasingly complex, and staying updated on the latest 510(k) guidelines is critical to maintaining regulatory approval and market access.

This training is designed for professionals involved in device design, modification, manufacturing, quality testing, and distribution—providing essential insights to help you make informed decisions about 510(k) submissions.

Key Reasons to Attend:

• • Stay Compliant with Confidence: Understand the FDA’s latest expectations for device and software modifications, and learn how to apply risk-based decision-making using FDA-provided flowcharts and decision guides.
  • Protect Patient Safety and Device Integrity: Ensure your changes do not compromise patient safety or device effectiveness. Gain clarity on evaluating significant changes and understanding when a new 510(k) is required.
  • Master Risk Assessment Techniques: Acquire actionable techniques to perform a risk assessment for device and software changes, a crucial first step in determining regulatory requirements.
  • Minimize Regulatory Delays: Avoid costly compliance errors by mastering the FDA’s structured approach, enabling you to make timely decisions on device changes without unnecessary delays.
  • Advance Your Career: Stay ahead in your field by demonstrating a clear understanding of FDA’s evolving guidelines for 510(k) submissions, a skillset increasingly valued in regulatory and quality roles.

By attending, you’ll gain practical tools to confidently manage software and device updates, make compliant decisions, and position yourself as a knowledgeable resource on FDA 510(k) requirements in your organization.

Don’t miss this opportunity to elevate your expertise and ensure compliance with the latest FDA guidelines.

Join Now!

Navigating FDA compliance for device and software changes is becoming increasingly complex, and staying updated on the latest 510(k) guidelines is critical to maintaining regulatory approval and market access.

This training is designed for professionals involved in device design, modification, manufacturing, quality testing, and distribution—providing essential insights to help you make informed decisions about 510(k) submissions.

Key Reasons to Attend:

• • Stay Compliant with Confidence: Understand the FDA’s latest expectations for device and software modifications, and learn how to apply risk-based decision-making using FDA-provided flowcharts and decision guides.
  • Protect Patient Safety and Device Integrity: Ensure your changes do not compromise patient safety or device effectiveness. Gain clarity on evaluating significant changes and understanding when a new 510(k) is required.
  • Master Risk Assessment Techniques: Acquire actionable techniques to perform a risk assessment for device and software changes, a crucial first step in determining regulatory requirements.
  • Minimize Regulatory Delays: Avoid costly compliance errors by mastering the FDA’s structured approach, enabling you to make timely decisions on device changes without unnecessary delays.
  • Advance Your Career: Stay ahead in your field by demonstrating a clear understanding of FDA’s evolving guidelines for 510(k) submissions, a skillset increasingly valued in regulatory and quality roles.

By attending, you’ll gain practical tools to confidently manage software and device updates, make compliant decisions, and position yourself as a knowledgeable resource on FDA 510(k) requirements in your organization.

Don’t miss this opportunity to elevate your expertise and ensure compliance with the latest FDA guidelines.

Join Now!

• • Understanding Medical Device Changes – Learn which device modifications may trigger the need for a new 510(k) submission, covering updates in labeling, technology, and materials.
  • Evaluating Software Changes – Gain insights on how to assess modifications in software applications associated with medical devices, including defect fixes, patches, and functional enhancements.
  • Navigating FDA Guidance Documents – Explore the latest FDA guidelines to understand regulatory expectations and compliance standards for device and software updates.
  • FDA Enforcement Insights – Get up-to-date on FDA enforcement practices related to 510(k) compliance and what it means for your organization.
  • Preparing New 510(k) Submissions – Learn the specific requirements for a new 510(k) submission, with practical steps to ensure compliance and mitigate risk.
  • Using FDA Flowcharts for Decision-Making – Master the FDA-provided flowcharts that guide decisions for:
    • Labeling Changes
    • Technology, Engineering, and Performance Adjustments
    • Material Modifications
    • Special Considerations for In Vitro Diagnostic Devices
  • Interactive Q&A Session – Participate in a dedicated Q&A session to clarify concepts and gain answers to specific compliance questions directly related to your organization’s needs.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

• • Understanding Medical Device Changes – Learn which device modifications may trigger the need for a new 510(k) submission, covering updates in labeling, technology, and materials.
  • Evaluating Software Changes – Gain insights on how to assess modifications in software applications associated with medical devices, including defect fixes, patches, and functional enhancements.
  • Navigating FDA Guidance Documents – Explore the latest FDA guidelines to understand regulatory expectations and compliance standards for device and software updates.
  • FDA Enforcement Insights – Get up-to-date on FDA enforcement practices related to 510(k) compliance and what it means for your organization.
  • Preparing New 510(k) Submissions – Learn the specific requirements for a new 510(k) submission, with practical steps to ensure compliance and mitigate risk.
  • Using FDA Flowcharts for Decision-Making – Master the FDA-provided flowcharts that guide decisions for:
    • Labeling Changes
    • Technology, Engineering, and Performance Adjustments
    • Material Modifications
    • Special Considerations for In Vitro Diagnostic Devices
  • Interactive Q&A Session – Participate in a dedicated Q&A session to clarify concepts and gain answers to specific compliance questions directly related to your organization’s needs.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Regulatory Affairs Professionals Seeking Clarity on FDA’s 510(k) Guidelines
  • Quality Assurance Managers Needing to Ensure Device Changes Meet FDA Standards
  • Product Development Leaders Focused on Integrating Regulatory Requirements Early On
  • Medical Device Engineers Evaluating Whether Changes Trigger 510(k) Filings
  • Software Development Teams Updating Medical Device Software
  • Compliance Officers Overseeing Risk Assessments for Device Modifications
  • Operations Managers Reducing Compliance-Related Delays in Product Launches
  • Executive Leaders Prioritizing Patient Safety in Product Modifications
  • Training and Development Heads Crafting Learning Paths on Regulatory Compliance

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Regulatory Affairs Professionals Seeking Clarity on FDA’s 510(k) Guidelines
  • Quality Assurance Managers Needing to Ensure Device Changes Meet FDA Standards
  • Product Development Leaders Focused on Integrating Regulatory Requirements Early On
  • Medical Device Engineers Evaluating Whether Changes Trigger 510(k) Filings
  • Software Development Teams Updating Medical Device Software
  • Compliance Officers Overseeing Risk Assessments for Device Modifications
  • Operations Managers Reducing Compliance-Related Delays in Product Launches
  • Executive Leaders Prioritizing Patient Safety in Product Modifications
  • Training and Development Heads Crafting Learning Paths on Regulatory Compliance