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Quality Management System and ISO 13485
The ISO 13485 standard is the international benchmark for quality management in the medical device industry. Its main goal is to ensure product safety and performance by anticipating risks and promoting continuous improvement throughout the design, manufacturing, and commercialization processes.
The ISO 13485 standard is organized into eight clauses, focusing on quality management systems for medical devices. It begins by defining the scope, normative references, and terms, then centers on requirements for the quality management system, management responsibility, resource management, product realization, and measurement, analysis, and improvement. Each section details how organizations must document, implement, and maintain processes to ensure both quality and regulatory compliance, including risk management, traceability, process validation, and comprehensive record keeping. Its structure is designed for applicability throughout the product lifecycle, covering activities from design and development, through production, distribution, and post-market support.
Key aspects of ISO 13485
Proactive risk management
The standard requires manufacturers to identify, analyze, and reduce risks from product design to retirement, ensuring patient and user safety.
Comprehensive traceability
Traceability is not just a regulatory requirement – it is vital for efficient safety alerts and recalls. Proper traceability enables rapid identification of issues and protects your company’s reputation.
Validation of critical processes
ISO 13485 urges manufacturers to prove that processes such as sterilization, packaging, or software really fulfill their purpose, preventing hidden failures that could affect product safety.
Continuous improvement and quality culture
The system promotes internal audits, regular reviews, and ongoing staff training, driving innovation and adaptability to regulatory changes.
Facilitates international market access
Compliance with ISO 13485 harmonizes regulatory requirements for major markets such as the European MDR, optimizing commercialization opportunities.
It's important to note that, as of today, achieving ISO 13485 certification does not automatically mean compliance with all FDA requirements. The FDA is currently harmonizing its regulation with ISO 13485 through the new QMSR rule, which will be fully enforced in 2026, yet some US-specific requirements will remain. Therefore, manufacturers must prepare their quality management system to address both standards and keep monitoring regulatory changes.