ISO 14155

ISO 14155 is an international standard titled "Clinical investigation of medical devices for human subjects — Good clinical practice". It outlines the requirements for planning, conducting, recording, and reporting clinical investigations carried out to assess the safety and performance of medical devices for human subjects. The standard aims to protect the rights, safety, and well-being of clinical trial participants while ensuring the reliability and credibility of the data generated.

ISO 14155 provides guidance for medical device manufacturers, sponsors, investigators, and ethics committees involved in clinical trials of medical devices. It addresses aspects such as:

• Ethical considerations: Emphasizing the importance of informed consent, data protection, and independent ethics committee review.
• Clinical trial design: Covering protocol development, study endpoints, patient selection, and data management.
• Investigator responsibilities: Defining the roles and responsibilities of investigators in conducting the clinical trial.
• Monitoring and auditing: Addressing the need for independent monitoring of clinical trials to ensure data integrity and compliance with the protocol and the standard.
• Data management and analysis: Detailing the requirements for data collection, storage, validation, and statistical analysis.
• Reporting: Covering the requirements for reporting clinical trial results.

Compliance with ISO 14155 is often a regulatory requirement in many countries for medical device manufacturers seeking to obtain market approval for their products. Adherence to the standard helps demonstrate that clinical investigations are conducted according to ethical and scientific principles, ensuring the safety and effectiveness of medical devices. The standard is periodically revised to reflect advancements in medical device technology and clinical trial methodologies.