Instructor :
Carolyn Troiano

Webinar ID:
13722

In today’s rapidly evolving medical technology landscape, cybersecurity is not just a compliance requirement—it’s a fundamental necessity for patient safety and trust.

With cyber threats becoming more sophisticated, medical device manufacturers, regulatory professionals, and healthcare organizations must stay ahead of evolving risks.

This 6-hour expert-led boot-camp provides a comprehensive, hands-on approach to medical device cybersecurity and FDA compliance.

Led by industry experts, this training will equip you with the latest regulatory insights, risk mitigation strategies, and best practices to safeguard medical device data from cyber threats.

What You’ll Learn:

• • Regulatory Frameworks & FDA Guidelines
    • • Gain a deep understanding of FDA’s latest cybersecurity policies, including key standards like IEC 62304, NIST, and ISO 14971.

• • Cybersecurity Risk Management
    • • Identify vulnerabilities, mitigate risks, and build robust cybersecurity frameworks to prevent data breaches.

• • Real-World Case Studies & Hands-On Strategies
    • • Apply proven techniques to analyze threats and implement security controls effectively.

• • Emerging Technologies & Future Trends
    • • Explore how AI, blockchain, and automation are shaping the future of medical device cybersecurity.

Key Benefits:

• • Stay compliant with the latest FDA and global cybersecurity regulations.
  • Enhance your professional expertise with cutting-edge cybersecurity skills.
  • Reduce security risks and strengthen organizational resilience against cyber threats.
  • Gain practical insights from top industry experts and apply them immediately.

Get ready to transform your cybersecurity knowledge and take the lead in securing medical devices.

Join this intensive bootcamp and stay ahead of evolving cyber threats!

Enroll Now!

In today’s rapidly evolving medical technology landscape, cybersecurity is not just a compliance requirement—it’s a fundamental necessity for patient safety and trust.

With cyber threats becoming more sophisticated, medical device manufacturers, regulatory professionals, and healthcare organizations must stay ahead of evolving risks.

This 6-hour expert-led boot-camp provides a comprehensive, hands-on approach to medical device cybersecurity and FDA compliance.

Led by industry experts, this training will equip you with the latest regulatory insights, risk mitigation strategies, and best practices to safeguard medical device data from cyber threats.

What You’ll Learn:

• • Regulatory Frameworks & FDA Guidelines
    • • Gain a deep understanding of FDA’s latest cybersecurity policies, including key standards like IEC 62304, NIST, and ISO 14971.

• • Cybersecurity Risk Management
    • • Identify vulnerabilities, mitigate risks, and build robust cybersecurity frameworks to prevent data breaches.

• • Real-World Case Studies & Hands-On Strategies
    • • Apply proven techniques to analyze threats and implement security controls effectively.

• • Emerging Technologies & Future Trends
    • • Explore how AI, blockchain, and automation are shaping the future of medical device cybersecurity.

Key Benefits:

• • Stay compliant with the latest FDA and global cybersecurity regulations.
  • Enhance your professional expertise with cutting-edge cybersecurity skills.
  • Reduce security risks and strengthen organizational resilience against cyber threats.
  • Gain practical insights from top industry experts and apply them immediately.

Get ready to transform your cybersecurity knowledge and take the lead in securing medical devices.

Join this intensive bootcamp and stay ahead of evolving cyber threats!

Enroll Now!

The medical device industry is at a critical crossroads, where cybersecurity threats are escalating, and FDA regulations are becoming more stringent.

Are your medical devices prepared? Missing out on the latest compliance updates could put patient safety, your organization’s reputation, and your career at risk.

This 6-hour intensive bootcamp is designed to help you navigate these challenges with confidence by equipping you with the latest FDA updates, advanced risk management strategies, and practical cybersecurity solutions.

Key Reasons to Attend:

• • Combat Rising Cyber Threats
    • • Medical devices are increasingly connected, making them vulnerable to sophisticated cyberattacks. Learn how to identify, mitigate, and prevent security breaches.

• • Stay Ahead of Regulatory Changes
    • • With evolving FDA cybersecurity mandates, non-compliance can lead to severe consequences. This bootcamp ensures you understand and implement the latest requirements.

• • Develop a Robust Security Framework
    • • Gain hands-on insights into building a solid cybersecurity plan, conducting risk assessments, and ensuring long-term device protection.

• • Enhance Your Career & Leadership Skills
    • • Mastering cybersecurity and regulatory compliance positions you as a key decision-maker in your organization, opening doors to leadership opportunities.

• • Apply Knowledge Immediately
    • • Through interactive discussions, real-world case studies, and expert guidance, you’ll leave with actionable strategies to strengthen your organization’s cybersecurity posture.

This isn’t just another compliance training—it’s your opportunity to become a proactive leader in securing medical devices.

Don’t wait until a cyber threat exposes vulnerabilities—take action now!

Join Now!

The medical device industry is at a critical crossroads, where cybersecurity threats are escalating, and FDA regulations are becoming more stringent.

Are your medical devices prepared? Missing out on the latest compliance updates could put patient safety, your organization’s reputation, and your career at risk.

This 6-hour intensive bootcamp is designed to help you navigate these challenges with confidence by equipping you with the latest FDA updates, advanced risk management strategies, and practical cybersecurity solutions.

Key Reasons to Attend:

• • Combat Rising Cyber Threats
    • • Medical devices are increasingly connected, making them vulnerable to sophisticated cyberattacks. Learn how to identify, mitigate, and prevent security breaches.

• • Stay Ahead of Regulatory Changes
    • • With evolving FDA cybersecurity mandates, non-compliance can lead to severe consequences. This bootcamp ensures you understand and implement the latest requirements.

• • Develop a Robust Security Framework
    • • Gain hands-on insights into building a solid cybersecurity plan, conducting risk assessments, and ensuring long-term device protection.

• • Enhance Your Career & Leadership Skills
    • • Mastering cybersecurity and regulatory compliance positions you as a key decision-maker in your organization, opening doors to leadership opportunities.

• • Apply Knowledge Immediately
    • • Through interactive discussions, real-world case studies, and expert guidance, you’ll leave with actionable strategies to strengthen your organization’s cybersecurity posture.

This isn’t just another compliance training—it’s your opportunity to become a proactive leader in securing medical devices.

Don’t wait until a cyber threat exposes vulnerabilities—take action now!

Join Now!

This 6-hour virtual bootcamp is structured into four in-depth sessions, providing a step-by-step approach to understanding and implementing medical device cybersecurity and FDA compliance. Each session builds upon the previous one, ensuring a comprehensive learning experience that combines theory, real-world applications, and interactive discussions.

Session 1: Foundations of Medical Device Cybersecurity (1.5 Hours)

• • Understanding Software in Medical Devices

    • Types of software and their applications in medical devices

    • Recent FDA focus and evolving cybersecurity concerns

  • Regulatory Landscape & Compliance Frameworks

    • Key FDA guidance documents and recent regulatory findings

    • Introduction to IEC 62304 and its role in cybersecurity

Session 2: Compliance, Quality Assurance & Regulatory Preparedness (1.5 Hours)

• • Navigating FDA Medical Device Cybersecurity Guidance

    • Understanding key compliance requirements and industry best practices

    • Other relevant regulatory frameworks impacting medical device security

  • Building a Strong Software Quality Assurance (SQA) Plan

    • Essential components for ensuring software integrity and compliance

  • Regulatory Oversight & Inspection Readiness

    • What to expect during FDA inspections and how to prepare

Session 3: System Integrity, Risk Management & Validation (1.5 Hours)

• • Ensuring System & Data Integrity

    • The role of GxP Systems and Computer System Validation (CSV)

  • Advanced Validation & Risk Management

    • Software Development Life Cycle (SDLC) methodologies

    • GAMP®5 Software Categorization and its impact on compliance

  • System Risk Assessment

    • Practical tools and techniques for identifying and mitigating risks

Session 4: Future Trends, Strategic Planning & Case Study Workshop (1.5 Hours)

• • Emerging Cybersecurity Threats & Innovations

    • The role of AI, blockchain, and automation in medical device security

  • Case Study: Real-World Cybersecurity Challenges & Solutions

    • Analyzing past breaches and industry responses

  • Strategic Workshop: Developing a Cybersecurity Response Plan

    • Hands-on session to apply learned concepts to real-world scenarios

  • Final Recap & Q&A

    • Review of key insights and an interactive discussion with experts

Looking for a Custom Training for Your Team?

We offer tailored sessions designed to meet your team’s specific cybersecurity and compliance needs.
📧 Contact us at support@compliancemeet.com to discuss custom training options available online or in-person.

This agenda ensures a structured, engaging, and practical learning experience, preparing participants to tackle real-world cybersecurity challenges with confidence.

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

This 6-hour virtual bootcamp is structured into four in-depth sessions, providing a step-by-step approach to understanding and implementing medical device cybersecurity and FDA compliance. Each session builds upon the previous one, ensuring a comprehensive learning experience that combines theory, real-world applications, and interactive discussions.

Session 1: Foundations of Medical Device Cybersecurity (1.5 Hours)

• • Understanding Software in Medical Devices

    • Types of software and their applications in medical devices

    • Recent FDA focus and evolving cybersecurity concerns

  • Regulatory Landscape & Compliance Frameworks

    • Key FDA guidance documents and recent regulatory findings

    • Introduction to IEC 62304 and its role in cybersecurity

Session 2: Compliance, Quality Assurance & Regulatory Preparedness (1.5 Hours)

• • Navigating FDA Medical Device Cybersecurity Guidance

    • Understanding key compliance requirements and industry best practices

    • Other relevant regulatory frameworks impacting medical device security

  • Building a Strong Software Quality Assurance (SQA) Plan

    • Essential components for ensuring software integrity and compliance

  • Regulatory Oversight & Inspection Readiness

    • What to expect during FDA inspections and how to prepare

Session 3: System Integrity, Risk Management & Validation (1.5 Hours)

• • Ensuring System & Data Integrity

    • The role of GxP Systems and Computer System Validation (CSV)

  • Advanced Validation & Risk Management

    • Software Development Life Cycle (SDLC) methodologies

    • GAMP®5 Software Categorization and its impact on compliance

  • System Risk Assessment

    • Practical tools and techniques for identifying and mitigating risks

Session 4: Future Trends, Strategic Planning & Case Study Workshop (1.5 Hours)

• • Emerging Cybersecurity Threats & Innovations

    • The role of AI, blockchain, and automation in medical device security

  • Case Study: Real-World Cybersecurity Challenges & Solutions

    • Analyzing past breaches and industry responses

  • Strategic Workshop: Developing a Cybersecurity Response Plan

    • Hands-on session to apply learned concepts to real-world scenarios

  • Final Recap & Q&A

    • Review of key insights and an interactive discussion with experts

Looking for a Custom Training for Your Team?

We offer tailored sessions designed to meet your team’s specific cybersecurity and compliance needs.
📧 Contact us at support@compliancemeet.com to discuss custom training options available online or in-person.

This agenda ensures a structured, engaging, and practical learning experience, preparing participants to tackle real-world cybersecurity challenges with confidence.

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!

• • Medical Device Manufacturers And Regulatory Compliance Professionals
  • Cybersecurity Specialists In The Healthcare And Life Sciences Industry
  • Quality Assurance And Risk Management Professionals
  • Software Engineers And IT Security Teams In MedTech
  • Regulatory Affairs And FDA Compliance Managers
  • Healthcare Data Privacy And Security Officers
  • Product Development Teams Focused On Medical Device Security
  • Clinical And Biomedical Engineers Handling Connected Devices

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

• • Medical Device Manufacturers And Regulatory Compliance Professionals
  • Cybersecurity Specialists In The Healthcare And Life Sciences Industry
  • Quality Assurance And Risk Management Professionals
  • Software Engineers And IT Security Teams In MedTech
  • Regulatory Affairs And FDA Compliance Managers
  • Healthcare Data Privacy And Security Officers
  • Product Development Teams Focused On Medical Device Security
  • Clinical And Biomedical Engineers Handling Connected Devices