Instructor :
Jose Mora

Webinar ID:
11795

In the dynamic world of medical devices, effective risk management is more critical than ever.

Are you confident your risk management strategy can keep pace with rapidly evolving device features and AI integrations?

As medical devices evolve with new design features and indications for use, so do the associated risks — from potential harm to patients to broader implications for property, the environment, and even your company’s compliance standing.

With medical technology advancing faster than ever, relying on outdated risk frameworks could leave your company exposed to unanticipated risks that weren’t even on the radar five years ago. How prepared are you for risks that emerge post-market?

This webinar dives deep into the ISO 14971 standard, guiding you through the entire risk management process, from initial design to post-market activities.

You’ll learn how to assess and mitigate risks across all phases of a device’s life cycle and supply chain, ensuring the highest level of safety and regulatory compliance.

Key focus areas include:

• • Identifying and addressing risks that evolve as your product develops new features or enters new markets.
  • Scrutinizing risks from every angle, whether related to patient safety, device failure, or broader environmental impacts.
  • Ensuring that vital risk management information is effectively transferred and maintained throughout a product’s lifecycle, even as projects change hands or move between departments and companies.
  • Building a risk management process that survives organizational changes, preserving critical information through every phase of development and production.

With increasing FDA oversight and the growing complexity of medical devices, now is the time to ensure your risk management practices are not only compliant with ISO 14971 but are also adaptable to new challenges and evolving regulatory requirements.

Don’t let regulatory blind spots or emerging risks catch your team off-guard.

Enroll Now!

In the dynamic world of medical devices, effective risk management is more critical than ever.

Are you confident your risk management strategy can keep pace with rapidly evolving device features and AI integrations?

As medical devices evolve with new design features and indications for use, so do the associated risks — from potential harm to patients to broader implications for property, the environment, and even your company’s compliance standing.

With medical technology advancing faster than ever, relying on outdated risk frameworks could leave your company exposed to unanticipated risks that weren’t even on the radar five years ago. How prepared are you for risks that emerge post-market?

This webinar dives deep into the ISO 14971 standard, guiding you through the entire risk management process, from initial design to post-market activities.

You’ll learn how to assess and mitigate risks across all phases of a device’s life cycle and supply chain, ensuring the highest level of safety and regulatory compliance.

Key focus areas include:

• • Identifying and addressing risks that evolve as your product develops new features or enters new markets.
  • Scrutinizing risks from every angle, whether related to patient safety, device failure, or broader environmental impacts.
  • Ensuring that vital risk management information is effectively transferred and maintained throughout a product’s lifecycle, even as projects change hands or move between departments and companies.
  • Building a risk management process that survives organizational changes, preserving critical information through every phase of development and production.

With increasing FDA oversight and the growing complexity of medical devices, now is the time to ensure your risk management practices are not only compliant with ISO 14971 but are also adaptable to new challenges and evolving regulatory requirements.

Don’t let regulatory blind spots or emerging risks catch your team off-guard.

Enroll Now!

• • Are you overwhelmed by the complexity of Risk Management documentation?
  • Is your risk management system agile enough to adapt to new market pressures?
  • Struggling to manage the endless files and redundant processes that pull valuable time and resources away from what really matters — actual risk mitigation?

If so, this webinar is exactly what you need.

In today’s highly regulated medical device industry, staying compliant with ISO 14971 while keeping up with evolving risks can feel like a constant uphill battle.

This training will show you how to streamline your entire risk management process, giving you practical tools to eliminate the repetitive, time-consuming documentation that slows your team down.

Here’s why you don’t want to miss this:

• Maximize Your Efficiency: Learn how to cut through the clutter and focus on what’s important — ensuring your devices are safe, compliant, and market-ready.
• Reduce the Documentation Overload: We’ll show you smart strategies to organize and manage risk data, so you can minimize redundancy and keep your projects moving forward.
• Refocus Your Team on What Matters: Free up your design and manufacturing teams from excessive paperwork and allow them to concentrate on risk mitigation and innovation.
• Stay Ahead of Regulatory Scrutiny: With the FDA tightening its focus on risk management, this webinar will ensure you’re fully prepared to meet the latest compliance expectations.

This isn’t just another course; it’s your key to unlocking a more efficient, effective risk management system.

Join Now!

• • Are you overwhelmed by the complexity of Risk Management documentation?
  • Is your risk management system agile enough to adapt to new market pressures?
  • Struggling to manage the endless files and redundant processes that pull valuable time and resources away from what really matters — actual risk mitigation?

If so, this webinar is exactly what you need.

In today’s highly regulated medical device industry, staying compliant with ISO 14971 while keeping up with evolving risks can feel like a constant uphill battle.

This training will show you how to streamline your entire risk management process, giving you practical tools to eliminate the repetitive, time-consuming documentation that slows your team down.

Here’s why you don’t want to miss this:

• Maximize Your Efficiency: Learn how to cut through the clutter and focus on what’s important — ensuring your devices are safe, compliant, and market-ready.
• Reduce the Documentation Overload: We’ll show you smart strategies to organize and manage risk data, so you can minimize redundancy and keep your projects moving forward.
• Refocus Your Team on What Matters: Free up your design and manufacturing teams from excessive paperwork and allow them to concentrate on risk mitigation and innovation.
• Stay Ahead of Regulatory Scrutiny: With the FDA tightening its focus on risk management, this webinar will ensure you’re fully prepared to meet the latest compliance expectations.

This isn’t just another course; it’s your key to unlocking a more efficient, effective risk management system.

Join Now!

• Introduction to Risk Management for Medical Devices
  • Overview of Risk Management Concepts and Importance in Regulatory Compliance.

• Understanding the Risk Management Process as per ISO 14971
  • Step-by-Step Breakdown of ISO 14971 and Its Application to Medical Devices.

• Defining Management Responsibilities in Risk Management
  • Key Roles and Responsibilities to Ensure Compliance and Effective Risk Mitigation.

• Developing and Implementing a Risk Management Plan
  • Essential Elements of a Risk Management Plan and How to Create a Comprehensive Strategy.

• Risk Identification, Evaluation, and Control
  • Practical Approaches to Identifying Risks and Implementing Risk Control Measures.

• Qualification and Competency of Personnel in Risk Management
  • Ensuring Your Team is Properly Trained and Qualified to Manage and Mitigate Risk.

• Creating and Maintaining a Risk Management File
  • Best Practices for Documenting and Storing Critical Risk Management Data.

• Integrating Risk Management with Design and Development Processes
  • Linking Risk Management with Design Controls to Ensure Comprehensive Coverage.

• Bringing It All Together: Practical Application of Risk Management in the Product Life Cycle
  • How Risk Management Interacts with Every Phase from Design to Post-Market.

BONUS:

• 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 Management for Medical Devices
  • Overview of Risk Management Concepts and Importance in Regulatory Compliance.

• Understanding the Risk Management Process as per ISO 14971
  • Step-by-Step Breakdown of ISO 14971 and Its Application to Medical Devices.

• Defining Management Responsibilities in Risk Management
  • Key Roles and Responsibilities to Ensure Compliance and Effective Risk Mitigation.

• Developing and Implementing a Risk Management Plan
  • Essential Elements of a Risk Management Plan and How to Create a Comprehensive Strategy.

• Risk Identification, Evaluation, and Control
  • Practical Approaches to Identifying Risks and Implementing Risk Control Measures.

• Qualification and Competency of Personnel in Risk Management
  • Ensuring Your Team is Properly Trained and Qualified to Manage and Mitigate Risk.

• Creating and Maintaining a Risk Management File
  • Best Practices for Documenting and Storing Critical Risk Management Data.

• Integrating Risk Management with Design and Development Processes
  • Linking Risk Management with Design Controls to Ensure Comprehensive Coverage.

• Bringing It All Together: Practical Application of Risk Management in the Product Life Cycle
  • How Risk Management Interacts with Every Phase from Design to Post-Market.

BONUS:

• 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!

• • Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
  • Research & Development
  • Quality Engineers and Auditors
  • Manufacturing Engineers
  • Regulatory Affairs Teams
  • Quality Assurance & Quality Control Teams
  • Operations Teams
  • Document Control
  • Design Assurance Teams
  • Device Development Teams
  • Personnel involved in Verification and Validation planning, execution and documentation for devices

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

• • Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
  • Research & Development
  • Quality Engineers and Auditors
  • Manufacturing Engineers
  • Regulatory Affairs Teams
  • Quality Assurance & Quality Control Teams
  • Operations Teams
  • Document Control
  • Design Assurance Teams
  • Device Development Teams
  • Personnel involved in Verification and Validation planning, execution and documentation for devices