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ISO 13485:2016 Medical Devices Quality Management System Implementation Training

  • Training Duration:
  • 5 Days
  • Training Environment:
  • On-site at the Institution
  • In DVA Classrooms
  • Online
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About the Training

ISO 13485:2016 Medical Devices Quality Management System Implementation Training focuses on quality standards in the medical device sector. Participants will learn the requirements of the ISO 13485:2016 standard and discover how to implement these standards in their own organizations. This implementation enhances product quality and patient safety.

The training emphasizes documentation and record management. Participants will learn how to create effective documentation systems, ensuring the traceability of quality management processes and guaranteeing regulatory compliance. This compliance increases the reliability of businesses.

Risk management and product safety are also covered in the training. Participants will learn how to assess risks during the development and production of medical devices. This assessment helps reduce risks and improve product safety, protecting both patient and user safety, and reinforcing brand reputation.

Supply chain management and subcontractor control are also addressed. Participants will learn how to effectively manage suppliers and subcontractors, ensuring quality and compliance throughout the supply chain, while also increasing process efficiency. This efficiency guarantees cost savings and timely delivery.

ISO 13485:2016 Medical Devices Quality Management System Implementation Training provides participants with practical skills, helping them effectively plan, implement, and manage medical device quality management systems. The training fosters expertise in medical device quality management, enabling participants to develop products that meet industry standards and regulatory requirements.

In conclusion, this training offers comprehensive knowledge of the ISO 13485:2016 standard. Participants will specialize in designing, implementing, and managing effective medical device quality management systems. By the end of the training, participants will possess strategic and operational skills in quality and compliance within the medical device sector, significantly contributing to their professional development.

What Will You Learn?

  • Fundamentals of ISO 13485:2016 Standard
  • Establishing a Medical Device Quality Management System
  • Documentation and Record Management
  • Risk Management and Product Development
  • Supply Chain Management and Supplier Audits
  • Internal and External Audits
  • Continuous Improvement and Quality Indicators
  • Real-World Scenarios and Application Examples

Prerequisites

  • Basic knowledge of quality management and medical devices
  • General understanding of ISO standards and regulatory requirements
  • Basic knowledge of the medical device industry and its processes

Who Should Attend?

  • Medical device industry professionals who want to establish and manage medical device quality management systems
  • Quality management system specialists who want to implement the ISO 13485:2016 standard
  • Individuals at all levels who want to develop their knowledge and skills in medical device quality and safety standards
  • Managers and employees working in the fields of medical device manufacturing, processing, and distribution

Outline

Here is the translation of your text into English:
Fundamentals of ISO 13485:2016 Standard
  • Overview and Key Principles of the Standard
  • Importance of Medical Device Quality Management Systems
Establishing a Medical Device Quality Management System
  • Planning and Implementation of System Setup
  • Management Responsibilities and Team Formation
Documentation and Record Management
  • Quality Documentation and Record Keeping
  • Documentation Systems and Management
Risk Management and Product Development
  • Risk Assessment and Management Processes
  • Product Design and Development
Supply Chain Management and Supplier Audits
  • Supplier Selection and Evaluation
  • Supply Chain Management and Audits
Internal and External Audits
  • Audit Planning and Execution
  • Evaluation of Audit Findings
Continuous Improvement and Quality Indicators
  • Performance Evaluation and Improvement Plans
  • Quality Indicators and Performance Measurement
Real-World Scenarios and Application Examples
  • Hands-on Case Studies
  • Discussions on Real-World Scenarios

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