ISO 13485 and Regulatory Requirements Essentials Training by Tonex
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:
- 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
- Quality Management System Requirements
- General requirements
- Documentation requirements
- Quality manual
- Control of documents and records
- Quality policy and objectives
- Management responsibility
- Resource Management
- Human resources
- Infrastructure requirements
- Work environment
- Training and competency
- Communication within the organization
- Supplier and vendor management
- 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
- 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
- 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