Instructor :
Charles H. Paul

Webinar ID:
13730

Medical device safety and effectiveness are critical throughout a product’s entire lifecycle. However, research shows that hazards from device use often pose greater risks than device failures themselves.

To mitigate these risks, regulatory agencies require a robust risk management process to ensure compliance and patient safety.

This 4-hour interactive virtual seminar provides a comprehensive guide to Risk Assessment and Hazard Analysis in the medical device industry. Participants will gain a clear understanding of regulatory expectations, industry standards, and best practices for conducting risk assessments effectively.

Key areas covered include:

• • Understanding Risk Management Frameworks
    • • Overview of ISO 14971 and 21 CFR 820 compliance requirements.

• • Identifying & Analyzing Risks
    • • Learn how to systematically assess potential hazards and their consequences.

• • Developing Risk Control Strategies
    • • Implement effective measures to minimize and mitigate identified risks.

• • Ensuring Compliance Throughout the Product Lifecycle
    • • Maintain risk management practices from design to post-market surveillance.

• • Practical Guidance from an Industry Expert –
    • • Led by Charles H. Paul, a regulatory consultant with over 20 years of experience in medical device compliance.

By the end of this seminar, participants will have the tools and knowledge to strengthen their risk management processes, meet regulatory expectations, and enhance medical device safety.

Don’t miss this opportunity to gain valuable regulatory insights and ensure your devices meet the highest safety standards!

Enroll Now!

Medical device safety and effectiveness are critical throughout a product’s entire lifecycle. However, research shows that hazards from device use often pose greater risks than device failures themselves.

To mitigate these risks, regulatory agencies require a robust risk management process to ensure compliance and patient safety.

This 4-hour interactive virtual seminar provides a comprehensive guide to Risk Assessment and Hazard Analysis in the medical device industry. Participants will gain a clear understanding of regulatory expectations, industry standards, and best practices for conducting risk assessments effectively.

Key areas covered include:

• • Understanding Risk Management Frameworks
    • • Overview of ISO 14971 and 21 CFR 820 compliance requirements.

• • Identifying & Analyzing Risks
    • • Learn how to systematically assess potential hazards and their consequences.

• • Developing Risk Control Strategies
    • • Implement effective measures to minimize and mitigate identified risks.

• • Ensuring Compliance Throughout the Product Lifecycle
    • • Maintain risk management practices from design to post-market surveillance.

• • Practical Guidance from an Industry Expert –
    • • Led by Charles H. Paul, a regulatory consultant with over 20 years of experience in medical device compliance.

By the end of this seminar, participants will have the tools and knowledge to strengthen their risk management processes, meet regulatory expectations, and enhance medical device safety.

Don’t miss this opportunity to gain valuable regulatory insights and ensure your devices meet the highest safety standards!

Enroll Now!

Navigating regulatory risk management requirements is not optional—it’s essential for ensuring medical device compliance, safety, and market approval.

Every major regulatory agency, including the FDA, Health Canada, EU Competent Authority, Australia TGA, and Japan MHLW, mandates a well-documented and effective risk management process.

Without a structured approach to risk assessment, companies face increased chances of product recalls, compliance failures, and safety concerns—all of which can lead to financial and reputational damage.

This seminar equips you with the tools and strategies to:

• • Develop a proactive risk management approach that integrates seamlessly into the design and lifecycle of medical devices.
  • Reduce the likelihood of recalls and compliance issues by mastering key risk analysis techniques such as Fault Tree Analysis (FTA), Failure Mode Effects Analysis (FMEA), and Failure Mode Effects and Criticality Analysis (FMECA).
  • Understand regulatory expectations and best practices for risk identification, evaluation, and mitigation.
  • Gain insights from an industry expert with over 20 years of experience in regulatory compliance and risk management.

Whether you’re involved in design, quality assurance, regulatory affairs, or risk management, this training will empower you with practical skills to safeguard your devices, patients, and business.

Secure your spot today! 🚀

Navigating regulatory risk management requirements is not optional—it’s essential for ensuring medical device compliance, safety, and market approval.

Every major regulatory agency, including the FDA, Health Canada, EU Competent Authority, Australia TGA, and Japan MHLW, mandates a well-documented and effective risk management process.

Without a structured approach to risk assessment, companies face increased chances of product recalls, compliance failures, and safety concerns—all of which can lead to financial and reputational damage.

This seminar equips you with the tools and strategies to:

• • Develop a proactive risk management approach that integrates seamlessly into the design and lifecycle of medical devices.
  • Reduce the likelihood of recalls and compliance issues by mastering key risk analysis techniques such as Fault Tree Analysis (FTA), Failure Mode Effects Analysis (FMEA), and Failure Mode Effects and Criticality Analysis (FMECA).
  • Understand regulatory expectations and best practices for risk identification, evaluation, and mitigation.
  • Gain insights from an industry expert with over 20 years of experience in regulatory compliance and risk management.

Whether you’re involved in design, quality assurance, regulatory affairs, or risk management, this training will empower you with practical skills to safeguard your devices, patients, and business.

Secure your spot today! 🚀

1. Introduction to Risk Analysis

• • • What is Risk Analysis? – Understanding its role in medical device safety and compliance.
    • Why is Risk/Hazard Analysis Important? – The impact of poor risk management on product recalls and regulatory penalties.

2. Regulatory Framework & Compliance Requirements

• • • Overview of Global Regulatory Expectations – FDA, Health Canada, EU MDR, TGA, and Japan MHLW.
    • ISO 14971 and Risk Management – Key principles and requirements.
    • Management Responsibility in Risk Management – The role of leadership in maintaining compliance.

3. Risk Management Process & Documentation

• • • Developing a Risk Management Plan – Structuring an effective risk strategy.
    • Essential Risk Management Documentation – What needs to be recorded and reported.

4. Risk Analysis Techniques & Evaluation Tools

• • • Key Questions to Ask in Risk Identification – Ensuring a thorough assessment.
    • Risk Evaluation & Analysis Methods:
      • Fault Tree Analysis (FTA) – Identifying root causes of potential failures.
      • Failure Mode Effects Analysis (FMEA) – Assessing failure modes and their impacts.
      • Failure Mode Effects and Criticality Analysis (FMECA) – Prioritizing risk based on severity.

5. Risk Control & Mitigation Strategies

• • • Developing Effective Risk Control Measures – Strategies to minimize identified risks.
    • The Risk Management Report – Compiling findings and demonstrating compliance.

6. Risk Management Beyond Product Design

• • • Production & Post-Production Risk Management – Ensuring ongoing compliance after market launch.
    • Common Challenges & Solutions:
      • Regulatory pitfalls and how to avoid them.
      • Human factors in risk management and common mistakes.

7. Final Considerations & Wrap-Up

• • • When is Risk Management Finished? – Understanding continuous monitoring and improvement.
    • Q&A with the Expert – Get your specific questions answered by an industry leader.

This structured agenda ensures a logical flow from foundational concepts to practical applications, equipping participants with valuable insights and hands-on knowledge.

BONUS:

1. 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.

1. Introduction to Risk Analysis

• • • What is Risk Analysis? – Understanding its role in medical device safety and compliance.
    • Why is Risk/Hazard Analysis Important? – The impact of poor risk management on product recalls and regulatory penalties.

2. Regulatory Framework & Compliance Requirements

• • • Overview of Global Regulatory Expectations – FDA, Health Canada, EU MDR, TGA, and Japan MHLW.
    • ISO 14971 and Risk Management – Key principles and requirements.
    • Management Responsibility in Risk Management – The role of leadership in maintaining compliance.

3. Risk Management Process & Documentation

• • • Developing a Risk Management Plan – Structuring an effective risk strategy.
    • Essential Risk Management Documentation – What needs to be recorded and reported.

4. Risk Analysis Techniques & Evaluation Tools

• • • Key Questions to Ask in Risk Identification – Ensuring a thorough assessment.
    • Risk Evaluation & Analysis Methods:
      • Fault Tree Analysis (FTA) – Identifying root causes of potential failures.
      • Failure Mode Effects Analysis (FMEA) – Assessing failure modes and their impacts.
      • Failure Mode Effects and Criticality Analysis (FMECA) – Prioritizing risk based on severity.

5. Risk Control & Mitigation Strategies

• • • Developing Effective Risk Control Measures – Strategies to minimize identified risks.
    • The Risk Management Report – Compiling findings and demonstrating compliance.

6. Risk Management Beyond Product Design

• • • Production & Post-Production Risk Management – Ensuring ongoing compliance after market launch.
    • Common Challenges & Solutions:
      • Regulatory pitfalls and how to avoid them.
      • Human factors in risk management and common mistakes.

7. Final Considerations & Wrap-Up

• • • When is Risk Management Finished? – Understanding continuous monitoring and improvement.
    • Q&A with the Expert – Get your specific questions answered by an industry leader.

This structured agenda ensures a logical flow from foundational concepts to practical applications, equipping participants with valuable insights and hands-on knowledge.

BONUS:

1. 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 Quality & Regulatory Affairs Professionals
  • Risk Management & Compliance Specialists
  • Product Development & Engineering Teams
  • Medical Device Manufacturers & Suppliers
  • R&D and Design Control Professionals
  • Quality Assurance & Quality Control Managers
  • Auditors & Compliance Consultants
  • Medical Device Consultants & Industry Experts

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

• • Medical Device Quality & Regulatory Affairs Professionals
  • Risk Management & Compliance Specialists
  • Product Development & Engineering Teams
  • Medical Device Manufacturers & Suppliers
  • R&D and Design Control Professionals
  • Quality Assurance & Quality Control Managers
  • Auditors & Compliance Consultants
  • Medical Device Consultants & Industry Experts