Instructor :
Charles H. Paul

Webinar ID:
9744

In 2025, the medical device industry is navigating a rapidly evolving landscape shaped by new regulatory updates, technological innovations, and increasing demands for sustainability and cybersecurity.

This 4-hour intensive bootcamp is specifically designed for quality and regulatory professionals seeking to integrate and align 21 CFR 820 and ISO 13485 standards within their organizations to meet today’s complex compliance requirements.

Gain practical insights and actionable strategies that help strengthen your quality systems, ensure regulatory compliance, and future-proof your processes.

Key Learning Areas Include:

• • Bridging Compliance and Innovation:
    • • Align quality frameworks with emerging digital technologies like AI and Machine Learning to enhance compliance processes.

• • Leading on Sustainability:
    • • Explore how Environmental, Social, and Governance (ESG) initiatives influence medical device manufacturing and quality expectations.

• • Adapting to Regulatory Shifts:
    • • Navigate the latest updates to 21 CFR 820 and ISO 13485, addressing the post-pandemic compliance environment and future regulatory trends.

• • Fortifying Cybersecurity:
    • • Build resilient systems for the Internet of Medical Things (IoMT) to mitigate risks associated with connected devices.

• • Preparing for Personalization:
    • • Understand how personalized medical devices and therapies are reshaping quality system requirements.

This bootcamp delivers real-world case studies, expert guidance, and practical tools to help you stay audit-ready and excel in 2025’s regulatory environment.

Enroll Now!

In 2025, the medical device industry is navigating a rapidly evolving landscape shaped by new regulatory updates, technological innovations, and increasing demands for sustainability and cybersecurity.

This 4-hour intensive bootcamp is specifically designed for quality and regulatory professionals seeking to integrate and align 21 CFR 820 and ISO 13485 standards within their organizations to meet today’s complex compliance requirements.

Gain practical insights and actionable strategies that help strengthen your quality systems, ensure regulatory compliance, and future-proof your processes.

Key Learning Areas Include:

• • Bridging Compliance and Innovation:
    • • Align quality frameworks with emerging digital technologies like AI and Machine Learning to enhance compliance processes.

• • Leading on Sustainability:
    • • Explore how Environmental, Social, and Governance (ESG) initiatives influence medical device manufacturing and quality expectations.

• • Adapting to Regulatory Shifts:
    • • Navigate the latest updates to 21 CFR 820 and ISO 13485, addressing the post-pandemic compliance environment and future regulatory trends.

• • Fortifying Cybersecurity:
    • • Build resilient systems for the Internet of Medical Things (IoMT) to mitigate risks associated with connected devices.

• • Preparing for Personalization:
    • • Understand how personalized medical devices and therapies are reshaping quality system requirements.

This bootcamp delivers real-world case studies, expert guidance, and practical tools to help you stay audit-ready and excel in 2025’s regulatory environment.

Enroll Now!

In the fast-paced and highly regulated medical device industry, staying ahead of evolving standards is critical.

This 4-hour training provides the essential knowledge and skills you need to navigate the complex landscape of FDA Quality System Regulation (21 CFR 820) and ISO 13485 with confidence and precision.

Key Benefits of Attending:

• • Master Compliance:
    • • Gain an in-depth understanding of FDA Quality System Regulation and ISO 13485, ensuring your organization meets the latest regulatory expectations.

• • Stay Ahead of Trends:
    • • Learn how emerging technologies like AI, IoMT, and digital transformation impact compliance and how to adapt effectively.

• • Mitigate Risks:
    • • Enhance your ability to address regulatory risks and maintain the safety and efficacy of medical devices, paving the way for smoother market access.

• • Boost Your Career: 
    • • Build expertise in critical regulatory frameworks, positioning yourself as a leader in quality assurance and regulatory affairs.

What Makes This Training Unique?

• • Engage with real-world case studies to understand practical applications.
  • Participate in interactive discussions that address specific challenges and offer actionable solutions.
  • Leave with tools and strategies you can immediately apply to your work, enabling you to make a tangible impact within your organization.

Whether you’re looking to expand your expertise or solidify your foundation in medical device regulations, this training equips you to excel in your role and advance your career.

Register Today and ensure you’re prepared to lead your organization into the future of medical device quality systems!

In the fast-paced and highly regulated medical device industry, staying ahead of evolving standards is critical.

This 4-hour training provides the essential knowledge and skills you need to navigate the complex landscape of FDA Quality System Regulation (21 CFR 820) and ISO 13485 with confidence and precision.

Key Benefits of Attending:

• • Master Compliance:
    • • Gain an in-depth understanding of FDA Quality System Regulation and ISO 13485, ensuring your organization meets the latest regulatory expectations.

• • Stay Ahead of Trends:
    • • Learn how emerging technologies like AI, IoMT, and digital transformation impact compliance and how to adapt effectively.

• • Mitigate Risks:
    • • Enhance your ability to address regulatory risks and maintain the safety and efficacy of medical devices, paving the way for smoother market access.

• • Boost Your Career: 
    • • Build expertise in critical regulatory frameworks, positioning yourself as a leader in quality assurance and regulatory affairs.

What Makes This Training Unique?

• • Engage with real-world case studies to understand practical applications.
  • Participate in interactive discussions that address specific challenges and offer actionable solutions.
  • Leave with tools and strategies you can immediately apply to your work, enabling you to make a tangible impact within your organization.

Whether you’re looking to expand your expertise or solidify your foundation in medical device regulations, this training equips you to excel in your role and advance your career.

Register Today and ensure you’re prepared to lead your organization into the future of medical device quality systems!

Module 1: Introduction to Quality Systems in the Medical Device Industry

• • Understanding the Role of Quality Systems in ensuring device safety, efficacy, and regulatory compliance.
  • Overview of Key Regulatory Standards:
    • • 21 CFR 820 – FDA Quality System Regulation (QSR).
      • ISO 13485 – Global Quality Management System (QMS) Standard.

Module 2: Navigating the Regulatory Framework

• • Comparing 21 CFR 820 and ISO 13485:
    • • Key similarities in structure and intent.
      • Key differences in regulatory focus and application.

• • Understanding the Broader Regulatory Landscape:
    • • FDA regulations specific to medical devices.
      • Global harmonization initiatives and regulatory convergence trends.

Module 3: Deep Dive into 21 CFR 820 – Quality System Regulation

• • Scope and Applicability of the FDA QSR.
  • Key Requirements and Subparts:
    • • Management Responsibility (Subpart B).
      • Design Controls (Subpart C).
      • Document Controls (Subpart D).
      • Production and Process Controls (Subpart E).
      • Corrective and Preventive Action (CAPA) (Subpart J).
      • Complaint Files (Subpart M).

Module 4: Understanding ISO 13485 – Quality Management Systems for Medical Devices

• • Purpose and Global Significance of ISO 13485.
  • Core Structure and Requirements:
    • • Management Responsibility (Clause 5).
      • Design and Development (Clause 7).
      • Production and Service Provision (Clause 7).
      • Measurement, Analysis, and Improvement (Clause 8).

• • Achieving and Maintaining ISO 13485 Certification:
    • • Documentation and record-keeping essentials.
      • Conducting internal and external audits effectively.

Module 5: Integrating 21 CFR 820 and ISO 13485 for Seamless Compliance

• • Developing an Integrated Quality Management System (QMS):
    • • Identifying overlapping requirements.
      • Streamlining processes for operational efficiency.

• • Ensuring Compliance with Evolving Standards:
    • • Staying updated on regulatory changes.
      • Adapting systems to meet new industry demands.

Module 6: Best Practices and Continuous Improvement in Quality Management

• • Implementing Best Practices:
    • • Effective risk management strategies.
      • Building robust training and competency programs.

• • Driving Continuous Improvement:
    • • Monitoring and measuring performance for system effectiveness.
      • Establishing feedback loops and optimizing processes for long-term success.

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

Module 1: Introduction to Quality Systems in the Medical Device Industry

• • Understanding the Role of Quality Systems in ensuring device safety, efficacy, and regulatory compliance.
  • Overview of Key Regulatory Standards:
    • • 21 CFR 820 – FDA Quality System Regulation (QSR).
      • ISO 13485 – Global Quality Management System (QMS) Standard.

Module 2: Navigating the Regulatory Framework

• • Comparing 21 CFR 820 and ISO 13485:
    • • Key similarities in structure and intent.
      • Key differences in regulatory focus and application.

• • Understanding the Broader Regulatory Landscape:
    • • FDA regulations specific to medical devices.
      • Global harmonization initiatives and regulatory convergence trends.

Module 3: Deep Dive into 21 CFR 820 – Quality System Regulation

• • Scope and Applicability of the FDA QSR.
  • Key Requirements and Subparts:
    • • Management Responsibility (Subpart B).
      • Design Controls (Subpart C).
      • Document Controls (Subpart D).
      • Production and Process Controls (Subpart E).
      • Corrective and Preventive Action (CAPA) (Subpart J).
      • Complaint Files (Subpart M).

Module 4: Understanding ISO 13485 – Quality Management Systems for Medical Devices

• • Purpose and Global Significance of ISO 13485.
  • Core Structure and Requirements:
    • • Management Responsibility (Clause 5).
      • Design and Development (Clause 7).
      • Production and Service Provision (Clause 7).
      • Measurement, Analysis, and Improvement (Clause 8).

• • Achieving and Maintaining ISO 13485 Certification:
    • • Documentation and record-keeping essentials.
      • Conducting internal and external audits effectively.

Module 5: Integrating 21 CFR 820 and ISO 13485 for Seamless Compliance

• • Developing an Integrated Quality Management System (QMS):
    • • Identifying overlapping requirements.
      • Streamlining processes for operational efficiency.

• • Ensuring Compliance with Evolving Standards:
    • • Staying updated on regulatory changes.
      • Adapting systems to meet new industry demands.

Module 6: Best Practices and Continuous Improvement in Quality Management

• • Implementing Best Practices:
    • • Effective risk management strategies.
      • Building robust training and competency programs.

• • Driving Continuous Improvement:
    • • Monitoring and measuring performance for system effectiveness.
      • Establishing feedback loops and optimizing processes for long-term success.

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

The following benefits from watching this. Even better when done as a group!

• • Regulatory Professionals Seeking to Master Compliance
  • Quality Assurance Experts Aiming for Operational Excellence
  • Leaders Driving Innovation While Ensuring Compliance
  • R&D Teams Developing Safer, Compliant Medical Devices
  • Manufacturing Heads Focused on Risk Mitigation
  • Training Coordinators Designing Learning Paths for Compliance Teams
  • HR Professionals Focused on Upskilling Teams in Medical Devices
  • Department Heads Seeking Cross-Functional Quality Integration
  • Professionals Navigating Emerging Trends in Quality Systems

The following benefits from watching this. Even better when done as a group!

• • Regulatory Professionals Seeking to Master Compliance
  • Quality Assurance Experts Aiming for Operational Excellence
  • Leaders Driving Innovation While Ensuring Compliance
  • R&D Teams Developing Safer, Compliant Medical Devices
  • Manufacturing Heads Focused on Risk Mitigation
  • Training Coordinators Designing Learning Paths for Compliance Teams
  • HR Professionals Focused on Upskilling Teams in Medical Devices
  • Department Heads Seeking Cross-Functional Quality Integration
  • Professionals Navigating Emerging Trends in Quality Systems