What is ISO 14155:2018?

In the field of medical devices, adherence to quality and safety standards is of utmost importance. One such standard that governs clinical investigations of medical devices is ISO 14155:2018. This international standard ensures the protection of human subjects and the reliability of clinical data collected during these investigations.

The Purpose of ISO 14155:2018

ISO 14155:2018 provides guidelines for the design, conduct, recording, and reporting of clinical investigations involving medical devices. The primary objective of this standard is to ensure the ethical and scientific integrity of these investigations. By following the guidelines outlined in ISO 14155:2018, manufacturers can demonstrate compliance with regulatory requirements and industry best practices.

Key Components of ISO 14155:2018

This standard covers various aspects of clinical investigations, including the responsibilities of the sponsor, investigator, and ethics committee. It outlines the necessary documentation, such as the investigational plan, informed consent forms, and case report forms. Furthermore, ISO 14155:2018 emphasizes the importance of ensuring subject safety, data confidentiality, and risk management throughout the investigation process.

Benefits of Compliance with ISO 14155:2018

Adhering to ISO 14155:2018 offers several benefits for manufacturers and stakeholders involved in clinical investigations. First and foremost, it instills confidence in the quality, safety, and effectiveness of the medical device being investigated. Compliance also facilitates regulatory approval by demonstrating the rigorous processes followed during the investigation. Moreover, adherence to ISO 14155:2018 promotes international harmonization, making it easier to conduct multi-center studies and collaborate across borders.