This comprehensive bundle combines introductory training on ISO 13485:2016 Medical Device Quality Management Systems (QMS) and ISO 14971:2019 Medical Device Risk Management. Designed for individuals seeking to understand the key standards that underpin medical device quality and safety, this bundle provides a practical overview of quality management system requirements and risk management principles throughout the product lifecycle.

Participants will explore the requirements of ISO 13485:2016, the internationally recognized standard for medical device quality management systems, and learn how it supports regulatory compliance, product quality, and customer confidence. The bundle also introduces ISO 14971:2019, providing insight into the systematic identification, evaluation, control, and monitoring of risks associated with medical devices from design and development through production and post-market activities.

Through these courses, learners will gain insight into how organizations can:

• Establish and maintain an effective medical device quality management system
• Apply risk management principles throughout the medical device lifecycle
• Enhance product safety, quality, and performance
• Support regulatory and compliance requirements within the medical device industry
• Improve decision-making related to product design, development, and manufacturing
• Integrate risk management activities into existing quality management processes

Who Should Attend?

This bundle is ideal for:

• Medical device professionals new to quality and risk management
• Quality Assurance and Quality Control personnel
• Regulatory Affairs professionals
• Product development and engineering teams
• Manufacturing professionals within the medical device sector
• Individuals responsible for implementing or maintaining ISO 13485 quality management systems
• Organizations seeking a foundational understanding of medical device quality and risk management requirements

Learning Outcomes

Upon completion, participants will be able to:

• Describe the purpose and key requirements of ISO 13485:2016.
• Explain the principles and processes defined within ISO 14971:2019.
• Understand how risk management supports the safety and effectiveness of medical devices.
• Recognize the relationship between ISO 13485:2016, ISO 14971:2019, and medical device regulatory requirements.
• Identify how quality and risk management activities are applied throughout the medical device lifecycle.
• Apply foundational quality and risk management concepts within a medical device organization.

Bundle Benefits

• Understand the requirements and structure of ISO 13485:2016
• Gain practical knowledge of ISO 14971:2019 risk management principles
• Learn how quality and risk management work together to support medical device safety and compliance
• Understand the relationship between medical device quality systems, risk management, and regulatory expectations
• Build a foundation for supporting quality management and risk management activities within medical device organizations
• Improve organizational readiness for medical device quality, compliance, and continual improvement initiatives

Whether you are new to the medical device industry or looking to strengthen your understanding of quality and risk management practices, this bundle provides the essential knowledge needed to support compliant, effective, and safe medical device lifecycle management.