Technical Articles

What is EN ISO 13485:2015?

EN ISO 13485:2015 is an international standard that specifies the requirements for a quality management system in medical device manufacturing companies. It outlines the criteria for establishing, implementing, and maintaining an effective quality management system to ensure the consistent design, development, production, and delivery of safe and effective medical devices.

Importance of EN ISO 13485:2015

The implementation of EN ISO 13485:2015 is crucial for medical device manufacturers as it demonstrates their commitment to producing high-quality and reliable products. Compliance with this standard helps companies meet regulatory requirements and gain a competitive edge in the market. It also ensures that all processes within the organization are well-documented, controlled, and consistently monitored to minimize risks and ensure product safety.

Main Requirements of EN ISO 13485:2015

EN ISO 13485:2015 requires medical device manufacturers to establish a comprehensive quality management system that covers various aspects of the product lifecycle. This includes clear documentation of procedures, adherence to strict design and development controls, establishment of risk management processes, implementation of effective control of suppliers and outsourced processes, as well as a strong focus on continuous improvement through monitoring, measurement, and analysis of key quality indicators.

Benefits of Implementing EN ISO 13485:2015

By implementing EN ISO 13485:2015, medical device manufacturers can reap numerous benefits. Firstly, it helps enhance customer satisfaction by ensuring the delivery of safe and effective products. The standard encourages organizations to identify and address potential risks and hazards associated with their products and processes, leading to improved product reliability. Additionally, compliance with EN ISO 13485:2015 increases market access opportunities as it aligns with regulatory requirements in many countries.



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