Instructor :
Jose Mora

Webinar ID:
12156

Risk management is more than just a regulatory requirement—it’s a critical component of every stage of the design control process.

As medical devices undergo continuous innovation, the risks associated with new features, evolving indications for use, and product lifecycle changes must be carefully managed to ensure both compliance and safety.

This 90-minute webinar will dive deep into the risk-based design control paradigm, offering practical strategies for applying risk management throughout the design control process.

Attendees will learn how to effectively scrutinize new design elements against potential risks to human health, property, and the environment across the entire product lifecycle and supply chain.

Key Takeaways:

• • Understand how risk management integrates into all phases of the design control process.
  • Learn how to evaluate evolving design features and medical indications for use against potential risks.
  • Explore best practices for ensuring that critical risk-related information is maintained across teams, departments, and projects, preventing knowledge gaps during handoffs.
  • Gain actionable insights on how to apply risk-based approaches that align with FDA regulations and global standards for medical device design.

What You’ll Gain:

• • Stay compliant with the latest FDA requirements by mastering risk-based design control.
  • Learn how to mitigate risk proactively, ensuring safer, more reliable medical devices.
  • Ensure your design processes are future-proof as regulations evolve.

Enroll Now!

Risk management is more than just a regulatory requirement—it’s a critical component of every stage of the design control process.

As medical devices undergo continuous innovation, the risks associated with new features, evolving indications for use, and product lifecycle changes must be carefully managed to ensure both compliance and safety.

This 90-minute webinar will dive deep into the risk-based design control paradigm, offering practical strategies for applying risk management throughout the design control process.

Attendees will learn how to effectively scrutinize new design elements against potential risks to human health, property, and the environment across the entire product lifecycle and supply chain.

Key Takeaways:

• • Understand how risk management integrates into all phases of the design control process.
  • Learn how to evaluate evolving design features and medical indications for use against potential risks.
  • Explore best practices for ensuring that critical risk-related information is maintained across teams, departments, and projects, preventing knowledge gaps during handoffs.
  • Gain actionable insights on how to apply risk-based approaches that align with FDA regulations and global standards for medical device design.

What You’ll Gain:

• • Stay compliant with the latest FDA requirements by mastering risk-based design control.
  • Learn how to mitigate risk proactively, ensuring safer, more reliable medical devices.
  • Ensure your design processes are future-proof as regulations evolve.

Enroll Now!

In the medical device industry, risk management is more complex than ever.

If you find yourself overwhelmed with managing redundant, repetitive, and disorganized risk management documentation, this webinar will provide a fresh, streamlined approach to simplify your processes.

Professionals in design, manufacturing, and risk management often spend excessive time on documentation rather than focusing on critical risk mitigation.

This course will equip you with the tools to shift from a documentation-heavy approach to a more efficient, risk-based design control strategy that boosts productivity and ensures compliance.

Here’s why attending this webinar is crucial for you:

• • Simplify Your Risk Management Process: Learn how to consolidate and organize your risk management files, making them easier to manage and maintain, saving your team valuable time.
  • Focus on What Matters Most: Free up your design and manufacturing resources to concentrate on actual risk mitigation, instead of getting bogged down by documentation tasks.
  • Stay Ahead of Regulatory Changes: Gain critical insights on how to align your risk management practices with evolving FDA regulations and global standards, ensuring compliance and reducing the risk of costly errors.
  • Improve Team Efficiency: Discover how to implement a more efficient risk-based approach that enhances team collaboration and reduces workflow bottlenecks.
  • Enhance Your Career: By mastering risk-based design control, you’ll position yourself as an expert in your field, opening up opportunities for career advancement and leadership roles.

Don’t miss out on this opportunity to learn cutting-edge strategies that will not only simplify your work but also improve your team’s performance and product outcomes.

Join Now!

In the medical device industry, risk management is more complex than ever.

If you find yourself overwhelmed with managing redundant, repetitive, and disorganized risk management documentation, this webinar will provide a fresh, streamlined approach to simplify your processes.

Professionals in design, manufacturing, and risk management often spend excessive time on documentation rather than focusing on critical risk mitigation.

This course will equip you with the tools to shift from a documentation-heavy approach to a more efficient, risk-based design control strategy that boosts productivity and ensures compliance.

Here’s why attending this webinar is crucial for you:

• • Simplify Your Risk Management Process: Learn how to consolidate and organize your risk management files, making them easier to manage and maintain, saving your team valuable time.
  • Focus on What Matters Most: Free up your design and manufacturing resources to concentrate on actual risk mitigation, instead of getting bogged down by documentation tasks.
  • Stay Ahead of Regulatory Changes: Gain critical insights on how to align your risk management practices with evolving FDA regulations and global standards, ensuring compliance and reducing the risk of costly errors.
  • Improve Team Efficiency: Discover how to implement a more efficient risk-based approach that enhances team collaboration and reduces workflow bottlenecks.
  • Enhance Your Career: By mastering risk-based design control, you’ll position yourself as an expert in your field, opening up opportunities for career advancement and leadership roles.

Don’t miss out on this opportunity to learn cutting-edge strategies that will not only simplify your work but also improve your team’s performance and product outcomes.

Join Now!

• • Introduction to Risk-Based Design Control
    Explore the evolution of design control, focusing on the 2019 approach and how it applies to today’s medical device landscape.
  • Regulatory Requirements: FDA and ISO Standards
    Understand what the FDA and ISO say about risk-based design control and how to ensure your company’s compliance with these critical regulations.
  • Presenting Risk-Based Design Control to Management
    Learn effective strategies for presenting the value of risk-based design control to senior management, helping to secure buy-in and resources.
  • Key Steps in Implementing Risk-Based Design Control
    Gain a step-by-step understanding of the essential phases of risk-based design control and how to integrate them into your company’s processes.
  • Practical Implementation in Your Organization
    Discover actionable tips for successfully implementing risk-based design control within your organization, minimizing risk and optimizing product design.
  • Bringing It All Together: Linking Design and Process
    Learn how to connect risk management, design control, and process controls to create a seamless, efficient workflow that ensures compliance and product safety.

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.

• • Introduction to Risk-Based Design Control
    Explore the evolution of design control, focusing on the 2019 approach and how it applies to today’s medical device landscape.
  • Regulatory Requirements: FDA and ISO Standards
    Understand what the FDA and ISO say about risk-based design control and how to ensure your company’s compliance with these critical regulations.
  • Presenting Risk-Based Design Control to Management
    Learn effective strategies for presenting the value of risk-based design control to senior management, helping to secure buy-in and resources.
  • Key Steps in Implementing Risk-Based Design Control
    Gain a step-by-step understanding of the essential phases of risk-based design control and how to integrate them into your company’s processes.
  • Practical Implementation in Your Organization
    Discover actionable tips for successfully implementing risk-based design control within your organization, minimizing risk and optimizing product design.
  • Bringing It All Together: Linking Design and Process
    Learn how to connect risk management, design control, and process controls to create a seamless, efficient workflow that ensures compliance and product safety.

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 Managers who need to ensure compliance with FDA and ISO standards while managing evolving design risks.
  • Quality Assurance Professionals seeking to enhance product safety and minimize risks throughout the product lifecycle.
  • Product Development Leaders aiming to streamline risk management and design control processes for faster approvals.
  • Design and Engineering Managers looking to optimize team efficiency by reducing time spent on documentation and focusing on risk mitigation.
  • Compliance Officers who want to stay ahead of regulatory changes and prevent costly compliance errors and product recalls.
  • Project Managers managing complex medical device development projects who need to ensure risk-based design control is implemented efficiently across teams.
  • R&D Teams seeking to innovate safely, while ensuring that all new design elements meet regulatory standards without slowing down development.
  • Manufacturing and Operations Heads who want to ensure their teams are aligned with risk-based control strategies to prevent production risks and maintain quality.
  • Healthcare Product Innovators striving to stay competitive by integrating risk-based design control into their product development for safer, faster-to-market devices.

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

• • Regulatory Affairs Managers who need to ensure compliance with FDA and ISO standards while managing evolving design risks.
  • Quality Assurance Professionals seeking to enhance product safety and minimize risks throughout the product lifecycle.
  • Product Development Leaders aiming to streamline risk management and design control processes for faster approvals.
  • Design and Engineering Managers looking to optimize team efficiency by reducing time spent on documentation and focusing on risk mitigation.
  • Compliance Officers who want to stay ahead of regulatory changes and prevent costly compliance errors and product recalls.
  • Project Managers managing complex medical device development projects who need to ensure risk-based design control is implemented efficiently across teams.
  • R&D Teams seeking to innovate safely, while ensuring that all new design elements meet regulatory standards without slowing down development.
  • Manufacturing and Operations Heads who want to ensure their teams are aligned with risk-based control strategies to prevent production risks and maintain quality.
  • Healthcare Product Innovators striving to stay competitive by integrating risk-based design control into their product development for safer, faster-to-market devices.