What is ISO-FDIS 14155:2014?

ISO-FDIS 14155:2014 is a standard developed by the International Organization for Standardization (ISO). It provides requirements on the design, conduct, and reporting of clinical investigations of medical devices used in human subjects. This standard aims to ensure that the data collected during such investigations are reliable and credible.

Background of ISO-FDIS 14155:2014

The need for a standardized approach to clinical investigations of medical devices became apparent due to variations in regulations across different countries. ISO-FDIS 14155:2014 was developed as an international consensus on best practices in this field. It takes into account ethical principles, safety requirements, and the need to protect patient rights and welfare.

Main Requirements of ISO-FDIS 14155:2014

ISO-FDIS 14155:2014 outlines the key aspects that need to be considered when conducting clinical investigations of medical devices. These include:

Study objectives and design: The standard emphasizes the importance of clearly defining study objectives and designing appropriate protocols for the investigation.

Ethics and patient protection: Ethical considerations, including informed consent, privacy, and confidentiality, should be integral to the study design.

Data collection and management: ISO-FDIS 14155:2014 requires accurate and reliable data collection methods, ensuring proper recording, verification, and retention of data.

Investigator responsibilities: The standard highlights the responsibilities of investigators, including their qualifications, training, and reporting obligations.

Adverse event reporting: Timely reporting and management of adverse events is emphasized to ensure patient safety.

Data analysis and reporting: The standard provides guidance on the analysis and reporting of data collected during the investigation, facilitating the evaluation of device performance.

Benefits of ISO-FDIS 14155:2014

Adhering to ISO-FDIS 14155:2014 brings several benefits. Firstly, it promotes harmonization of clinical investigation requirements across different jurisdictions, simplifying compliance for medical device manufacturers. Secondly, it enhances patient safety and protection by establishing rigorous standards for study design and conduct. Thirdly, it improves the credibility of data generated during the investigations, facilitating regulators' assessment of device safety and efficacy. Lastly, standardization fosters global collaboration and exchange of knowledge in the field of medical device research.

In conclusion, ISO-FDIS 14155:2014 is an important standard that sets out requirements for the design, conduct, and reporting of clinical investigations of medical devices used in humans. By promoting best practices and maintaining high standards of ethical conduct, this standard ensures the reliability and credibility of data generated through such investigations, benefiting both manufacturers and patients.