ISO 13485:2016 Compliance Mastery: Lean Solutions for Streamlined Quality and Growth

Master ISO 13485:2016 Updates Using Lean Strategies for Efficiency and Compliance Success!

Instructor :
Jose Mora

Webinar ID:
12150

Date: NOV 06, 2024 (WED)

Start Time: 10 AM PT - 11:30 AM PT

Duration: 90 Mins.

Buy This Course in a Pack of 3 courses at 35% Discount HERE:

🔍 The Medical Device Risk & Quality Mastery Bundle (3 Courses)

“Navigate the Complexities of Medical Device Compliance with Confidence!”

Courses Included:

    1. ISO 14971 Compliance for 2025: Proactive Risk Management for Medical Devices (duration 90 mins.), find out more details here
    2. ISO 13485:2016 Compliance Mastery: Lean Solutions for Streamlined Quality and Growth (duration 90 mins.), find out more details here
    3. Master Risk-Based Design Control: The Key to Compliant and Innovative Medical Device Design (duration 90 mins.), find out more details here

This Bundle Empowers You To:

    • Master Risk Management: Implement ISO 14971:2007 standards to mitigate risks associated with medical devices.

Buy This Course in a Pack of 3 courses at 35% Discount HERE:

🔍 The Medical Device Risk & Quality Mastery Bundle (3 Courses)

“Navigate the Complexities of Medical Device Compliance with Confidence!”

Courses Included:

    1. ISO 14971 Compliance for 2025: Proactive Risk Management for Medical Devices (duration 90 mins.), find out more details here
    2. ISO 13485:2016 Compliance Mastery: Lean Solutions for Streamlined Quality and Growth (duration 90 mins.), find out more details here
    3. Master Risk-Based Design Control: The Key to Compliant and Innovative Medical Device Design (duration 90 mins.), find out more details here

This Bundle Empowers You To:

    • Master Risk Management: Implement ISO 14971:2007 standards to mitigate risks associated with medical devices.
    • Achieve Quality Excellence: Understand ISO 13485:2016 requirements using lean principles to enhance your quality management system.
    • Innovate with Confidence: Apply risk-based design control methodologies to streamline medical device design processes.

Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!

                     Buy All 3 Courses at a 35% discount HERE

What will you learn

    • Introduction To Lean Documents And ISO 13485:2016 Key Differences
    • Understand Systemic, Management, Resource, And Realization Requirements For Compliance
    • Learn Risk-Based Approach, Medical Device File, And Record Keeping
    • Explore Product Realization, Process Validation, And Design & Development Processes
    • Master Handling Complaints, Nonconforming Products, And Regulatory Requirements
    • Apply Lean Principles To Streamline Quality Management System Processes
    • Integrate Continuous Improvement For Long-Term Compliance And Operational Success
    • Introduction To Lean Documents And ISO 13485:2016 Key Differences
    • Understand Systemic, Management, Resource, And Realization Requirements For Compliance
    • Learn Risk-Based Approach, Medical Device File, And Record Keeping
    • Explore Product Realization, Process Validation, And Design & Development Processes
    • Master Handling Complaints, Nonconforming Products, And Regulatory Requirements
    • Apply Lean Principles To ….

Course Description

In today’s highly regulated medical device industry, compliance with ISO 13485:2016 is crucial. The latest revision introduces significant changes, and designers and manufacturers must not only comply but do so with precision and efficiency.

This 90-minute webinar will equip you with the tools and knowledge to streamline your compliance efforts using Lean Principles, ensuring that each step in your manufacturing process—work instructions, SOPs, equipment maintenance, and support functions—is controlled and documented.

Rather than waiting to be caught off guard by these new requirements, you’ll learn how to proactively prepare, avoiding costly mistakes and operational inefficiencies.

Key Benefits:

    • Understand the ISO 13485:2016 updates and their implications for your organization’s quality management system.
    • Learn how to integrate Lean Principles to improve efficiency while maintaining strict regulatory compliance.
    • Discover how to simplify and streamline processes, using Lean Documents and Lean Configuration to reduce complexity and ensure accurate, controlled records.

Don’t let these changes surprise you. Join us to gain the insights and strategies needed to stay ahead of the curve, reduce compliance stress, and enhance operational efficiency.

Key Takeaways:

    • ISO 13485:2016 updates and how they impact your business.
    • Proven Lean strategies to streamline compliance and improve productivity.
    • Actionable steps to implement the changes across your organization’s quality processes.

This webinar will provide clarity, confidence, and a solid foundation to tackle the new compliance landscape head-on.

Why This Matters: The ISO 13485:2016 revision is a game-changer, requiring organizations to reassess their processes and documentation. By understanding these changes now, you can prepare your team, reduce the risk of non-compliance, and optimize your operations for success.

Join us and stay compliant while improving efficiency. Let Lean Principles guide your ISO 13485:2016 implementation.

Enroll Now!

In today’s highly regulated medical device industry, compliance with ISO 13485:2016 is crucial. The latest revision introduces significant changes, and designers and manufacturers must not only comply but do so with precision and efficiency.

This 90-minute webinar will equip you with the tools and knowledge to streamline your compliance efforts using Lean Principles, ensuring that each step in your manufacturing process—work instructions, SOPs, equipment maintenance, and support functions—is controlled and documented.

Rather than waiting to be caught off guard by these new requirements, you’ll learn how to proactively prepare, avoiding costly mistakes and operational inefficiencies.

Key Benefits:

    • Understand the ISO 13485:2016 updates and their implications for your organization’s quality management system.
    • Learn how to integrate Lean Principles to improve efficiency while maintaining strict regulatory compliance.
    • Discover how to simplify and streamline processes, using Lean Documents and Lean Configuration to reduce complexity and ensure accurate, controlled records.

Don’t let these changes surprise you. Join us to gain the insights and strategies needed to stay ahead of the curve, reduce compliance stress, and enhance operational efficiency.

Key Takeaways:

    • ISO 13485:2016 updates and how they impact your business.
    • Proven Lean strategies to streamline compliance and improve productivity.
    • Actionable steps to implement the changes across your organization’s quality processes.

This webinar will provide clarity, confidence, and a solid foundation to tackle the new compliance landscape head-on.

Why This Matters: The ISO 13485:2016 revision is a game-changer, requiring organizations to reassess their processes and documentation. By understanding these changes now, you can prepare your team, reduce the risk of non-compliance, and optimize your operations for success.

Join us and stay compliant while improving efficiency. Let Lean Principles guide your ISO 13485:2016 implementation.

Enroll Now!

Why you should attend

Staying compliant with ISO 13485:2016 isn’t just about ticking boxes—it’s about ensuring the long-term success of your organization.

The latest updates introduce significant changes that, if left unaddressed, can result in compliance risks, operational inefficiencies, and increased scrutiny from regulators.

This 90-minute webinar offers a unique opportunity to not only understand the new requirements but also leverage Lean Principles to simplify your processes, reduce costs, and boost efficiency. By attending, you will gain actionable insights that go beyond compliance and help you transform your quality management system into a streamlined, well-documented, and compliant operation.

Key reasons why you can’t afford to miss this webinar:

    • Avoid costly mistakes: Get ahead of the ISO 13485:2016 updates and ensure your processes are fully compliant, reducing the risk of penalties or failed audits.
    • Boost productivity and efficiency: Learn how to integrate Lean strategies that eliminate waste, optimize workflows, and improve overall performance.
    • Proactive problem-solving: Equip yourself with the skills to address compliance challenges before they escalate, saving time and resources.
    • Expert guidance: Receive industry-specific, actionable strategies that will empower you to apply what you’ve learned immediately to your job role.

By mastering these new compliance demands, you’ll be able to confidently navigate the changes and position your organization for future success.

This webinar will give you the knowledge and tools to not only meet regulatory requirements but to excel in a competitive landscape.

Invest in your compliance skills and future-proof your organization. Don’t wait for surprises—prepare now.

Join Now!

Staying compliant with ISO 13485:2016 isn’t just about ticking boxes—it’s about ensuring the long-term success of your organization.

The latest updates introduce significant changes that, if left unaddressed, can result in compliance risks, operational inefficiencies, and increased scrutiny from regulators.

This 90-minute webinar offers a unique opportunity to not only understand the new requirements but also leverage Lean Principles to simplify your processes, reduce costs, and boost efficiency. By attending, you will gain actionable insights that go beyond compliance and help you transform your quality management system into a streamlined, well-documented, and compliant operation.

Key reasons why you can’t afford to miss this webinar:

    • Avoid costly mistakes: Get ahead of the ISO 13485:2016 updates and ensure your processes are fully compliant, reducing the risk of penalties or failed audits.
    • Boost productivity and efficiency: Learn how to integrate Lean strategies that eliminate waste, optimize workflows, and improve overall performance.
    • Proactive problem-solving: Equip yourself with the skills to address compliance challenges before they escalate, saving time and resources.
    • Expert guidance: Receive industry-specific, actionable strategies that will empower you to apply what you’ve learned immediately to your job role.

By mastering these new compliance demands, you’ll be able to confidently navigate the changes and position your organization for future success.

This webinar will give you the knowledge and tools to not only meet regulatory requirements but to excel in a competitive landscape.

Invest in your compliance skills and future-proof your organization. Don’t wait for surprises—prepare now.

Join Now!

Areas Covered

    • Introduction to Lean Documents and Lean Configuration
      Gain a foundational understanding of how Lean Principles can reduce complexity in your documentation and configuration processes.
    • ISO 13485:2016 vs. ISO 13485:2003
      Understand the key differences between the 2003 and 2016 revisions, and how the new standards impact your organization.
    • Overview of ISO 13485:2016
      Explore the scope and purpose of the latest ISO 13485 standard, focusing on its implications for medical device manufacturers.
    • Systemic Requirements
      Learn about the overall quality management system (QMS) structure and requirements for establishing effective processes.
    • Management Requirements
      Discover the leadership responsibilities outlined in the standard, including top management’s role in ensuring compliance.
    • Resource Requirements
      Understand how to effectively allocate resources—such as personnel, infrastructure, and environment—to meet the standard.
    • Realization Requirements
      Review the necessary steps for bringing a medical device from concept to market in compliance with ISO 13485.
    • Remedial Requirements
      Examine the processes for handling corrective and preventive actions (CAPA) to address nonconformities.
    • Changes in ISO 13485:2016
      Get an in-depth look at the new requirements introduced in the 2016 version and how they differ from previous standards.
    • Regulatory Requirements
      Stay updated on global regulatory demands and how ISO 13485:2016 aligns with them.
    • Risk-Based Approach
      Learn how to incorporate a risk-based mindset into your QMS to ensure patient safety and product quality.
    • Medical Device File and Record Keeping
      Understand the importance of maintaining comprehensive records for each device and ensuring traceability throughout the lifecycle.
    • Product Realization and Process Validation
      Review the steps to ensure that your products meet customer requirements and are validated for use.
    • User Training and Design & Development
      Learn the importance of thorough user training and how to manage the design and development processes effectively.
    • Purchasing and Servicing
      Explore requirements for controlling supplier quality and providing servicing support for medical devices.
    • Handling Complaints and Nonconforming Products
      Develop strategies for managing product complaints and nonconforming products, ensuring they are resolved efficiently.
    • Continuous Improvement
      Discover how to implement a culture of continuous improvement in your quality management processes.
    • Applying Lean Principles Across the QMS
      Learn how to create continuity between the various elements of your QMS while avoiding unnecessary complexity and redundancy.
    • Bringing It All Together
      Consolidate your knowledge by understanding how all these elements work cohesively to create a streamlined, compliant, and efficient QMS.

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 Lean Documents and Lean Configuration
      Gain a foundational understanding of how Lean Principles can reduce complexity in your documentation and configuration processes.
    • ISO 13485:2016 vs. ISO 13485:2003
      Understand the key differences between the 2003 and 2016 revisions, and how the new standards impact your organization.
    • Overview of ISO 13485:2016
      Explore the scope and purpose of the latest ISO 13485 standard, focusing on its implications for medical device manufacturers.
    • Systemic Requirements
      Learn about the overall quality management system (QMS) structure and requirements for establishing effective processes.
    • Management Requirements
      Discover the leadership responsibilities outlined in the standard, including top management’s role in ensuring compliance.
    • Resource Requirements
      Understand how to effectively allocate resources—such as personnel, infrastructure, and environment—to meet the standard.
    • Realization Requirements
      Review the necessary steps for bringing a medical device from concept to market in compliance with ISO 13485.
    • Remedial Requirements
      Examine the processes for handling corrective and preventive actions (CAPA) to address nonconformities.
    • Changes in ISO 13485:2016
      Get an in-depth look at the new requirements introduced in the 2016 version and how they differ from previous standards.
    • Regulatory Requirements
      Stay updated on global regulatory demands and how ISO 13485:2016 aligns with them.
    • Risk-Based Approach
      Learn how to incorporate a risk-based mindset into your QMS to ensure patient safety and product quality.
    • Medical Device File and Record Keeping
      Understand the importance of maintaining comprehensive records for each device and ensuring traceability throughout the lifecycle.
    • Product Realization and Process Validation
      Review the steps to ensure that your products meet customer requirements and are validated for use.
    • User Training and Design & Development
      Learn the importance of thorough user training and how to manage the design and development processes effectively.
    • Purchasing and Servicing
      Explore requirements for controlling supplier quality and providing servicing support for medical devices.
    • Handling Complaints and Nonconforming Products
      Develop strategies for managing product complaints and nonconforming products, ensuring they are resolved efficiently.
    • Continuous Improvement
      Discover how to implement a culture of continuous improvement in your quality management processes.
    • Applying Lean Principles Across the QMS
      Learn how to create continuity between the various elements of your QMS while avoiding unnecessary complexity and redundancy.
    • Bringing It All Together
      Consolidate your knowledge by understanding how all these elements work cohesively to create a streamlined, compliant, and efficient QMS.

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.

Who is this course for

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

    • Quality Managers Seeking to streamline their processes and ensure full compliance with ISO 13485:2016 updates.
    • Regulatory Affairs Professionals Looking to understand new standards and avoid compliance pitfalls that could lead to costly delays or penalties.
    • Medical Device Manufacturers Aiming to implement Lean Principles for more efficient production workflows while staying compliant with regulatory changes.
    • Operations Directors Focused on improving operational efficiency by integrating compliant, yet simplified, quality management systems.
    • Product Development Teams Needing to align their design and development processes with the updated ISO 13485:2016 requirements to ensure product safety and quality.
    • Supply Chain Managers Who want to ensure their purchasing and supplier processes meet the rigorous standards without sacrificing speed or quality.
    • HR and Training Professionals Responsible for ensuring that teams are equipped with the latest knowledge to handle compliance changes effectively.
    • Compliance Officers Tasked with staying ahead of regulatory updates and ensuring that all processes are fully auditable and traceable.
    • Lean and Continuous Improvement Specialists Looking to apply Lean strategies to simplify documentation and improve overall organizational efficiency while adhering to ISO 13485.

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

    • Quality Managers Seeking to streamline their processes and ensure full compliance with ISO 13485:2016 updates.
    • Regulatory Affairs Professionals Looking to understand new standards and avoid compliance pitfalls that could lead to costly delays or penalties.
    • Medical Device Manufacturers Aiming to implement Lean Principles for more efficient production workflows while staying compliant with regulatory changes.
    • Operations Directors Focused on improving operational efficiency by integrating compliant, yet simplified, quality management systems.
    • Product Development Teams Needing to align their design and development processes with the updated ISO 13485:2016 requirements to ensure product safety and quality.
    • Supply Chain Managers Who want to ensure their purchasing and supplier processes meet the rigorous standards without sacrificing speed or quality.
    • HR and Training Professionals Responsible for ensuring that teams are equipped with the latest knowledge to handle compliance changes effectively.
    • Compliance Officers Tasked with staying ahead of regulatory updates and ensuring that all processes are fully auditable and traceable.
    • Lean and Continuous Improvement Specialists Looking to apply Lean strategies to simplify documentation and improve overall organizational efficiency while adhering to ISO 13485.

Instructor Profile

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and ....

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.

Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices.

José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.

He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.

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