Length: 2 Days
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ISO 13485 and Regulatory Requirements Essentials Training by Tonex

Biomedical Imaging and Signal Processing

The ISO 13485 and Regulatory Requirements Essentials course by Tonex provides an in-depth understanding of the ISO 13485 standard and its regulatory implications in the medical device industry. This training is designed to help participants comprehend the requirements necessary for a quality management system (QMS) that consistently meets customer and regulatory demands.

Learning Objectives:

  • Understand the structure and key elements of ISO 13485.
  • Learn the requirements for a comprehensive quality management system.
  • Gain insights into regulatory requirements associated with ISO 13485.
  • Develop skills to implement and maintain compliance with ISO 13485.
  • Understand how to prepare for ISO 13485 certification audits.
  • Learn best practices for integrating ISO 13485 with other regulatory standards.

Audience:

  • Quality Assurance Managers
  • Regulatory Affairs Specialists
  • Medical Device Manufacturers
  • Quality Control Personnel
  • Compliance Officers
  • Consultants and Auditors in the medical device industry

Program Modules:

  1. Introduction to ISO 13485
    • Overview of ISO 13485
    • Importance of ISO 13485 in the medical device industry
    • Key terms and definitions
    • Scope of ISO 13485
    • Structure of the standard
    • Benefits of implementing ISO 13485
  2. Quality Management System Requirements
    • General requirements
    • Documentation requirements
    • Quality manual
    • Control of documents and records
    • Quality policy and objectives
    • Management responsibility
  3. Resource Management
    • Human resources
    • Infrastructure requirements
    • Work environment
    • Training and competency
    • Communication within the organization
    • Supplier and vendor management
  4. Product Realization
    • Planning of product realization
    • Customer-related processes
    • Design and development
    • Purchasing and supply chain management
    • Production and service provision
    • Control of monitoring and measuring equipment
  5. Measurement, Analysis, and Improvement
    • General principles of measurement and analysis
    • Internal audits
    • Monitoring and measurement of processes
    • Control of nonconforming product
    • Analysis of data
    • Continual improvement and corrective actions
  6. Regulatory Requirements and Compliance
    • Overview of regulatory requirements
    • FDA and CE marking
    • Risk management and regulatory compliance
    • Post-market surveillance and vigilance
    • Regulatory audits and inspections
    • Integration with other quality standards and regulations

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