What is ISO/FDIS 18153:2014 ?

Title: Understanding ISO/FDIS 18153:2014 - The Global Standard for Medical Device Trials

The International Organization for Standardization (ISO) is a prominent organization that develops and publishes various standards for different industries and sectors. One of the key standards that ISO publishes is ISO-FDIS 14155:2014, which is a global standard for the design, conduct, and reporting of clinical investigations of medical devices used in human subjects. This standard is designed to ensure that the data collected during such investigations are reliable and credible. In this article, we will discuss the importance of ISO-FDIS 14155:2014 and its implications for the medical device industry.

Importance of ISO-FDIS 14155:2014

ISO-FDIS 14155:2014 is an essential standard for the medical device industry. It provides a framework for the design, conduct, and reporting of clinical investigations of medical devices used in human subjects. The standard aims to ensure that the data collected during such investigations are reliable and credible, which is critical for ensuring the safety and effectiveness of medical devices.

ISO-FDIS 14155:2014 is important for several reasons. Firstly, it helps to ensure that medical device manufacturers conduct clinical investigations in accordance with a standardized framework. This helps to reduce variations in the conduct of clinical investigations and ensures that the data collected is consistent and comparable across different manufacturers.

Secondly, ISO-FDIS 14155:2014 helps to ensure that the data collected during clinical investigations is reliable and credible. The standard provides a set of requirements for the design, conduct, and reporting of clinical investigations, which ensures that the data collected is accurate and reflects the true safety and effectiveness of the medical device.

ISO-FDIS 14155:2014 also helps to ensure that medical device manufacturers comply with regulatory requirements for the design, manufacture, and reporting of medical devices. The standard is based on good clinical practice (GCP), which is a set of principles that guide the conduct of clinical investigations. It is important for medical device manufacturers to ensure that they comply with GCP to ensure that their products are safe and effective for use.

Conclusion

ISO-FDIS 14155:2014 is a critical standard for the medical device industry. It provides a framework for the design, conduct, and reporting of clinical investigations of medical devices used in human subjects. It is important for medical device manufacturers to ensure that they comply with the requirements of ISO-FDIS 14155:2014 to ensure that their products are safe and effective for use. By following the standard, manufacturers can ensure that the data collected during clinical investigations is reliable and credible, which is critical for ensuring the safety and effectiveness of medical devices.