ISO 14971 Compliance for 2025: Proactive Risk Management for Medical Devices
Don’t Wait Until 2025—Fix Your Risk Management Gaps Today!
Instructor :
Jose Mora
Webinar ID:
12143
Date: DEC 24, 2024 (TUE)
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:
-
- ISO 14971 Compliance for 2025: Proactive Risk Management for Medical Devices (duration 90 mins.), find out more details here
- ISO 13485:2016 Compliance Mastery: Lean Solutions for Streamlined Quality and Growth (duration 90 mins.), find out more details here
- 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:
-
- ISO 14971 Compliance for 2025: Proactive Risk Management for Medical Devices (duration 90 mins.), find out more details here
- ISO 13485:2016 Compliance Mastery: Lean Solutions for Streamlined Quality and Growth (duration 90 mins.), find out more details here
- 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
-
- Understand Risk Management Process as per ISO 14971 Standards.
- Explore Management Responsibilities for Effective Risk Management Implementation.
- Learn Personnel Qualification Requirements for Managing Risk Processes.
- Develop a Comprehensive and Practical Risk Management Plan.
- Maintain a Complete, Up-to-Date Risk Management File.
- Integrate Risk Management into Product Design and ….
-
- Understand Risk Management Process as per ISO 14971 Standards.
- Explore Management Responsibilities for Effective Risk Management Implementation.
- Learn Personnel Qualification Requirements for Managing Risk Processes.
- Develop a Comprehensive and Practical Risk Management Plan.
- Maintain a Complete, Up-to-Date Risk Management File.
- Integrate Risk Management into Product Design and Manufacturing Processes.
- Apply Actionable Strategies to Enhance Compliance and Product Safety.
Course Description
As ISO 14971 continues to be the gold standard for risk management in medical devices, staying ahead of updates and understanding how to apply this framework is crucial for professionals like you.
This 90-minute webinar will provide a comprehensive yet concise guide to mastering ISO 14971, equipping you with the tools needed to manage risks across the entire product lifecycle.
From design to post-market surveillance, this course will help you mitigate potential harms to patients, reduce regulatory risks, and ensure your devices remain compliant in 2024 and beyond.
What You’ll Learn:
-
- Key risk management principles as defined by ISO 14971 and how to apply them across different phases of product development.
- How to assess and control risks related to design changes, new medical indications, and product updates.
- Strategies to ensure safety and compliance throughout the supply chain and the product lifecycle.
- How to maintain the integrity of critical information during hand-offs between teams and organizations, minimizing risks that arise during knowledge transfer.
Key Takeaways:
-
- Stay compliant with the latest ISO 14971 standards and avoid costly mistakes or regulatory penalties.
- Gain actionable insights that can be applied immediately to enhance risk management within your projects.
- Learn in just 90 minutes—a focused, time-efficient approach designed for busy professionals who need impactful results fast.
Whether you are involved in regulatory affairs, quality assurance, or product development, this webinar will give you the knowledge and confidence to navigate risk management challenges in 2024.
Enroll Now!
As ISO 14971 continues to be the gold standard for risk management in medical devices, staying ahead of updates and understanding how to apply this framework is crucial for professionals like you.
This 90-minute webinar will provide a comprehensive yet concise guide to mastering ISO 14971, equipping you with the tools needed to manage risks across the entire product lifecycle.
From design to post-market surveillance, this course will help you mitigate potential harms to patients, reduce regulatory risks, and ensure your devices remain compliant in 2024 and beyond.
What You’ll Learn:
-
- Key risk management principles as defined by ISO 14971 and how to apply them across different phases of product development.
- How to assess and control risks related to design changes, new medical indications, and product updates.
- Strategies to ensure safety and compliance throughout the supply chain and the product lifecycle.
- How to maintain the integrity of critical information during hand-offs between teams and organizations, minimizing risks that arise during knowledge transfer.
Key Takeaways:
-
- Stay compliant with the latest ISO 14971 standards and avoid costly mistakes or regulatory penalties.
- Gain actionable insights that can be applied immediately to enhance risk management within your projects.
- Learn in just 90 minutes—a focused, time-efficient approach designed for busy professionals who need impactful results fast.
Whether you are involved in regulatory affairs, quality assurance, or product development, this webinar will give you the knowledge and confidence to navigate risk management challenges in 2024.
Enroll Now!
Why you should attend
In today’s complex medical device landscape, effective risk management isn’t just about compliance—it’s about ensuring safety, improving efficiency, and staying ahead of industry changes.
This 90-minute webinar is designed to help you streamline your risk management processes, reduce unnecessary documentation, and focus on what truly matters: mitigating risks and improving device safety.
Why You Should Attend:
-
- Simplify Your Risk Management Process: If you’re overwhelmed with managing redundant, clustered risk management documents, this course will provide you with actionable strategies to reduce inefficiencies and simplify documentation without compromising quality.
- Enhance Efficiency in Your Role: Are your teams spending more time on documentation than on actual risk mitigation? Learn how to shift focus from paperwork to active risk management, ensuring your resources are allocated more efficiently.
- Stay Compliant with Evolving Standards: With the ISO 14971 standard continually evolving, it’s essential to stay updated on the latest requirements. This webinar will help you ensure your processes are compliant and ready for future regulatory changes.
- Improve Product Safety and Market Readiness: By mastering risk management, you’ll help your organization create safer medical devices, ensuring quicker market access and fewer compliance issues down the line.
- Advance Your Career: As risk management becomes increasingly critical in the medical device industry, gaining expertise in ISO 14971 will position you as a valuable asset within your organization, enhancing both your skills and career trajectory.
Don’t miss this opportunity to learn practical, time-saving techniques that will immediately impact how you manage risk for medical devices.
Register today and equip yourself with the knowledge to overcome common challenges and lead your team with confidence!
In today’s complex medical device landscape, effective risk management isn’t just about compliance—it’s about ensuring safety, improving efficiency, and staying ahead of industry changes.
This 90-minute webinar is designed to help you streamline your risk management processes, reduce unnecessary documentation, and focus on what truly matters: mitigating risks and improving device safety.
Why You Should Attend:
-
- Simplify Your Risk Management Process: If you’re overwhelmed with managing redundant, clustered risk management documents, this course will provide you with actionable strategies to reduce inefficiencies and simplify documentation without compromising quality.
- Enhance Efficiency in Your Role: Are your teams spending more time on documentation than on actual risk mitigation? Learn how to shift focus from paperwork to active risk management, ensuring your resources are allocated more efficiently.
- Stay Compliant with Evolving Standards: With the ISO 14971 standard continually evolving, it’s essential to stay updated on the latest requirements. This webinar will help you ensure your processes are compliant and ready for future regulatory changes.
- Improve Product Safety and Market Readiness: By mastering risk management, you’ll help your organization create safer medical devices, ensuring quicker market access and fewer compliance issues down the line.
- Advance Your Career: As risk management becomes increasingly critical in the medical device industry, gaining expertise in ISO 14971 will position you as a valuable asset within your organization, enhancing both your skills and career trajectory.
Don’t miss this opportunity to learn practical, time-saving techniques that will immediately impact how you manage risk for medical devices.
Register today and equip yourself with the knowledge to overcome common challenges and lead your team with confidence!
Areas Covered
-
- Risk Management Process as per ISO 14971: Gain a clear understanding of the ISO 14971 framework and how to implement it across the entire product lifecycle, from design to post-market surveillance.
- Management Responsibilities: Explore the critical role of leadership in driving effective risk management strategies and ensuring compliance with ISO 14971 requirements.
- Qualification of Personnel: Learn how to identify and train qualified personnel to take responsibility for key aspects of risk management, ensuring consistency and compliance.
- Risk Management Plan: Discover how to develop a comprehensive risk management plan that outlines the processes, timelines, and resources required to mitigate risks at every stage.
- Risk Management File: Understand the structure and importance of maintaining a complete and up-to-date risk management file, ensuring that documentation meets regulatory standards and supports effective decision-making.
- Bringing It All Together – Links to Design and Process: See how all aspects of risk management tie into the design and manufacturing processes, ensuring that risks are addressed proactively, efficiently, and with a focus on compliance and safety.
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
-
- Risk Management Process as per ISO 14971: Gain a clear understanding of the ISO 14971 framework and how to implement it across the entire product lifecycle, from design to post-market surveillance.
- Management Responsibilities: Explore the critical role of leadership in driving effective risk management strategies and ensuring compliance with ISO 14971 requirements.
- Qualification of Personnel: Learn how to identify and train qualified personnel to take responsibility for key aspects of risk management, ensuring consistency and compliance.
- Risk Management Plan: Discover how to develop a comprehensive risk management plan that outlines the processes, timelines, and resources required to mitigate risks at every stage.
- Risk Management File: Understand the structure and importance of maintaining a complete and up-to-date risk management file, ensuring that documentation meets regulatory standards and supports effective decision-making.
- Bringing It All Together – Links to Design and Process: See how all aspects of risk management tie into the design and manufacturing processes, ensuring that risks are addressed proactively, efficiently, and with a focus on compliance and safety.
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- 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!
-
- Team Leaders Seeking to Strengthen Risk Management Strategies and Compliance
- Department Heads Focused on Improving Regulatory Compliance and Product Safety
- Professionals Wanting to Master Risk Management for Career Advancement
- Training Managers Designing Learning Paths to Improve Team Efficiency
- HR Professionals Focused on Upgrading Workforce Skills for Compliance
- Quality Assurance Managers Seeking to Reduce Risk and Avoid Penalties
- Regulatory Affairs Specialists Striving for Up-to-Date Compliance Expertise
- Product Managers Focused on Integrating Risk Management into Development Processes
- Manufacturing Supervisors Wanting to Minimize Production Risks and Ensure Safety
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Team Leaders Seeking to Strengthen Risk Management Strategies and Compliance
- Department Heads Focused on Improving Regulatory Compliance and Product Safety
- Professionals Wanting to Master Risk Management for Career Advancement
- Training Managers Designing Learning Paths to Improve Team Efficiency
- HR Professionals Focused on Upgrading Workforce Skills for Compliance
- Quality Assurance Managers Seeking to Reduce Risk and Avoid Penalties
- Regulatory Affairs Specialists Striving for Up-to-Date Compliance Expertise
- Product Managers Focused on Integrating Risk Management into Development Processes
- Manufacturing Supervisors Wanting to Minimize Production Risks and Ensure Safety
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 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.
