What is EN ISO 13485:2012+AC:2015?

In the medical industry, ensuring the safety, effectiveness, and quality of medical devices is of utmost importance. In order to adhere to these high standards, medical device manufacturers must comply with various regulations and standards. One such standard is EN ISO 13485:2012+AC:2015.

The Purpose and Scope

The EN ISO 13485:2012+AC:2015 standard specifies requirements for a quality management system specific to medical devices. It encompasses the entire life cycle of a medical device, from design and development to production, installation, and servicing.

The main purpose of this standard is to facilitate compliance with regulatory requirements and demonstrate the ability to consistently design, develop, and produce medical devices that meet customer and regulatory requirements.

Key Requirements

EN ISO 13485:2012+AC:2015 outlines several key requirements that organizations must fulfill in order to obtain and maintain certification:

Management responsibility: The organization's top management must ensure the effective implementation of the quality management system and its overall performance.

Resource management: Adequate resources, including personnel, infrastructure, and work environment, must be provided to ensure the quality of the medical devices.

Product realization: This stage involves planning, designing, and developing the medical device, as well as controlling production processes and product release.

Measurement, analysis, and improvement: Regular monitoring, measurement, and analysis of the quality management system's performance are essential to identify areas for improvement and take appropriate corrective actions.

The Benefits of Compliance

Complying with EN ISO 13485:2012+AC:2015 brings numerous benefits to medical device manufacturers. Firstly, it ensures that the organization operates under a well-documented quality management system, leading to improved efficiency and effectiveness throughout the entire production process.

Secondly, certification demonstrates to regulatory authorities and customers that the manufacturer meets internationally recognized standards for the design, development, and production of medical devices. This helps build trust and confidence in the products, resulting in increased marketability.

Lastly, compliance with this standard aligns with risk management principles, allowing organizations to identify and mitigate potential risks associated with their devices. By implementing controls and systematic processes, better product outcomes can be achieved, enhancing patient safety.