Introduction to ISO 15223-1:2021 & ISO 20417:2021- Medical Device Labeling Training by Tonex
This comprehensive course by Tonex provides a detailed exploration of ISO 15223-1:2021 and ISO 20417:2021 standards, focusing on their critical role in medical device labeling. Participants will gain a deep understanding of the regulatory requirements, labeling symbols, and information necessary for compliance in the rapidly evolving landscape of the medical device industry.
Embark on a comprehensive journey into the intricacies of medical device labeling with Tonex’s training on ISO 15223-1:2021 and ISO 20417:2021 standards. This specialized course delves into the critical elements of these standards, equipping participants with essential knowledge for navigating the evolving regulatory landscape.
Explore the nuances of ISO 15223-1:2021, understand the latest updates in ISO 20417:2021, and master the art of compliance in medical device labeling. With Tonex’s expert-led training, participants gain a strategic advantage by honing their skills in interpretation, risk management, and efficient processes, ensuring they are well-equipped to meet industry demands and regulatory expectations.
Learning Objectives:
- Understand the key principles and requirements outlined in ISO 15223-1:2021.
- Familiarize yourself with the latest updates in ISO 20417:2021 for medical device labeling.
- Gain insights into the regulatory landscape governing medical device labeling.
- Learn to interpret and apply labeling symbols according to ISO standards.
- Acquire knowledge on risk management considerations in medical device labeling.
- Develop the skills to ensure compliance and streamline labeling processes within your organization.
Audience: This course is designed for regulatory affairs professionals, quality assurance personnel, labeling specialists, and individuals involved in the design, manufacturing, and distribution of medical devices. It is also beneficial for professionals seeking to enhance their understanding of global labeling standards and best practices.
Course Outline:
Module 1: Introduction to ISO 15223-1:2021
- Overview of ISO 15223-1:2021
- Scope and Purpose of the Standard
- Key Terminology and Definitions
- Regulatory Framework Surrounding ISO 15223-1
- Evolution of the Standard
- Case Studies Illustrating Standard Implementation
Module 2: ISO 20417:2021 – Updates and Implications
- Changes and Additions in ISO 20417:2021
- Impact on Medical Device Labeling Practices
- Integration with ISO 15223-1:2021
- Case Studies Highlighting Standard Application
- Addressing Industry Challenges with ISO 20417
- Future Trends and Anticipated Developments
Module 3: Regulatory Landscape for Medical Device Labeling
- Global Regulatory Requirements Overview
- Recent Updates in Medical Device Labeling Regulations
- Harmonization Initiatives and their Impact
- Case Studies on Regulatory Compliance
- Best Practices for Navigating Regulatory Challenges
- Strategies for Adapting to Evolving Regulatory Trends
Module 4: Labeling Symbols and Interpretation
- Comprehensive Analysis of ISO Symbolism
- Interpretation of Key Symbols in Medical Device Labeling
- Practical Application Exercises
- Addressing Common Interpretation Challenges
- Symbolism Alignment with Regulatory Requirements
- Emerging Trends in Labeling Symbols and Graphics
Module 5: Risk Management in Medical Device Labeling
- Understanding Risk Considerations in Labeling
- Integrating Risk Management into Labeling Processes
- Risk Assessment Methodologies
- Case Studies on Risk Management in Labeling
- Regulatory Expectations Regarding Risk Mitigation
- Continuous Improvement in Risk Management Strategies
Module 6: Ensuring Compliance and Streamlining Processes
- Best Practices for Ensuring Compliance
- Strategies for Efficient Labeling Processes
- Quality Control Measures in Labeling
- Automation and Technology Solutions
- Case Studies on Successful Compliance Implementation
- Continuous Improvement and Adaptation Strategies for Labeling Processes