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Overview of ISO 13485:2016 – Medical Devices Quality Management Systems Training

Length: 2 Days
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Overview of ISO 13485:2016 – Medical Devices Quality Management Systems Training by Tonex

FMEA, FTA and Risk Assessment for Medical Devices

The ISO 13485:2016 – Medical Devices Quality Management Systems Training by Tonex provides a comprehensive understanding of the requirements and principles of ISO 13485:2016. This course is designed to equip participants with the knowledge and skills necessary to implement and maintain a quality management system (QMS) for medical devices. Participants will learn about the regulatory requirements, risk management, and the essential elements of ISO 13485:2016. Through interactive sessions, case studies, and practical exercises, this training ensures that attendees are well-prepared to meet the stringent standards of the medical device industry.

Learning Objectives:

  • Understand ISO 13485:2016 Requirements: Gain a thorough understanding of the structure, requirements, and principles of ISO 13485:2016.
  • Implement a QMS: Learn how to develop, implement, and maintain a quality management system that complies with ISO 13485:2016.
  • Regulatory Compliance: Understand the regulatory requirements and how to ensure compliance with ISO 13485:2016.
  • Risk Management: Learn about risk management processes and how to apply them in the context of medical device quality management.
  • Continuous Improvement: Understand the importance of continuous improvement and how to implement it within a QMS framework.
  • Audit Preparation: Prepare for internal and external audits by understanding audit processes and requirements.

Audience:

  • Quality Managers and Engineers
  • Regulatory Affairs Professionals
  • Medical Device Manufacturers
  • Quality Assurance Professionals
  • Internal Auditors
  • Compliance Officers
  • Anyone involved in the development, implementation, and maintenance of a QMS for medical devices

Course Modules:

Module 1: Introduction to ISO 13485:2016

    • Overview of ISO 13485:2016
    • Key changes from previous versions
    • Importance and benefits of ISO 13485:2016

Module 2: Quality Management System (QMS) Requirements

    • Structure and elements of ISO 13485:2016
    • Documentation requirements
    • Management responsibility

Module 3: Risk Management in Medical Devices

    • Risk management principles
    • ISO 14971 and its relationship with ISO 13485
    • Risk management process and implementation

Module 4: Design and Development Controls

    • Design and development planning
    • Design inputs and outputs
    • Design verification and validation
    • Design transfer and changes

Module 5: Production and Process Controls

    • Production planning
    • Process validation
    • Control of monitoring and measuring equipment
    • Identification and traceability

Module 6: Regulatory Requirements and Compliance

    • Overview of global regulatory requirements
    • FDA QSR and ISO 13485:2016
    • CE marking and MDR compliance

Module 7: Internal and External Audits

    • Preparing for audits
    • Conducting internal audits
    • Handling external audits and inspections
    • Non-conformance management and corrective actions

Module 8: Supplier and Outsourcing Controls

    • Supplier evaluation and selection
    • Supplier monitoring and re-evaluation
    • Outsourcing controls and management

Module 9: Continuous Improvement

    • Quality improvement methodologies
    • CAPA (Corrective and Preventive Actions)
    • Data analysis and performance measurement

Module 10: Case Studies and Practical Exercises

    • Real-world case studies
    • Group discussions
    • Practical exercises for implementation and compliance

The ISO 13485:2016 – Medical Devices Quality Management Systems Training by Tonex is designed to provide participants with the knowledge and tools needed to successfully implement and maintain a QMS that meets ISO 13485:2016 standards. Through this training, participants will be better equipped to ensure the quality, safety, and efficacy of medical devices in compliance with global regulatory requirements.

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