What is EN ISO 13485:2016-AC:2017?

EN ISO 13485:2016-AC:2017 refers to the latest revision of the international standard for quality management systems specific to the medical device industry. This standard, developed by the International Organization for Standardization (ISO) and adopted by the European Committee for Standardization (CEN), provides a framework for organizations involved in the design, development, production, and distribution of medical devices. It outlines the requirements for implementing an effective quality management system to ensure compliance with regulatory and customer requirements.

The Key Elements of EN ISO 13485:2016-AC:2017

The revised version of EN ISO 13485 places greater emphasis on risk management and the involvement of top management in the quality management system. It introduces several key elements that organizations need to consider when implementing or transitioning to this standard.

One important aspect is the inclusion of a risk management process throughout the product lifecycle. This means that manufacturers must identify and assess risks associated with their medical devices and implement appropriate measures to mitigate potential harm to patients or users. Risk management should be a continuous process, involving regular review and updating as necessary.

Another crucial element is the increased focus on supply chain control. Organizations are now required to ensure the effective control and traceability of outsourced processes and products. This includes assessing the competence and reliability of suppliers, establishing clear communication channels, and conducting regular audits to verify compliance.

The Benefits of EN ISO 13485:2016-AC:2017 Compliance

Complying with EN ISO 13485:2016-AC:2017 brings numerous benefits to medical device manufacturers and other stakeholders in the industry. Firstly, it enhances confidence in the quality and safety of medical devices, both within the organization and among customers. By implementing a robust quality management system, organizations can reduce the risk of product recalls, non-compliance with regulatory requirements, and adverse events related to device use.

Additionally, EN ISO 13485:2016-AC:2017 compliance fosters greater international market access. Many countries require medical device manufacturers to demonstrate compliance with this standard before they can sell their products within their jurisdiction. By obtaining CE marking, which indicates compliance with European Union (EU) health, safety, and environmental standards, organizations can access the EU medical device market and expand their global reach.

Conclusion

EN ISO 13485:2016-AC:2017 is a significant standard for ensuring quality management in the medical device industry. Its focus on risk management, supply chain control, and top management involvement helps organizations improve patient safety and product quality while meeting regulatory obligations. Complying with this standard provides various benefits, including enhanced confidence, reduced risks, and increased market access. Organizations should strive to implement and maintain an effective quality management system based on EN ISO 13485:2016-AC:2017 to stay competitive in the dynamic medical device market.