ISO 13485 is a globally recognized standard for quality management systems specific to the medical device industry. Developed by the International Organization for Standardization (ISO), it establishes the requirements for ensuring medical devices meet safety and performance standards. The standard focuses on risk management, regulatory compliance, and effective process validation throughout the product lifecycle.
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ISO 13485 PPT: Certification, Training & Resources
ISO 13485 applies to organizations involved in the design, production, installation, and servicing of medical devices, aiming to enhance operational efficiency and market access by demonstrating a commitment to quality and safety. While certification is not mandatory, it offers a competitive edge by building trust with stakeholders and facilitating global trade.
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The latest version, ISO 13485:2016, emphasizes risk-based decision-making and aligns with contemporary quality management practices. Implementing this standard helps organizations ensure consistent design, development, production, and delivery of safe and effective medical devices.
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Table of Content for ISO 13485 PPT
- Introduction to ISO 13485
- Scope and Purpose
- Key Definitions
- Quality Management System (QMS) Requirements
- Risk Management
- Design and Development
- Production and Service Provision
- Management Responsibilities
- Conclusion
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