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Patient safety is a key ISO priority.Clinical investigation of medical devices are strictly regulated with numerous regional and national regulations and requirements that must be followed by manufacturers and researchers, as well as other parties involved in clinical trials.
ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practice, helps manufacturers comply with the requirements for good clinical practice in the design, conduct and reporting of clinical investigations.
The ISO 14155 standard, widely used in industry, has been revised to reflect recent changes in regulations and amendments to other related standards. The updated version also contains a lot of additional details and information designed to help protect clinical trial participants and users of medical equipment and achieve intended results.
This standard is intended to guarantee the rights, safety and well-being of trial participants and includes requirements for an appropriate methodology to ensure the scientific validity of clinical data. It defines the responsibilities of sponsors and researchers and clarifies the role of ethics committees, regulators, safety councils and other parties involved in research projects.
ISO 14155 has also been aligned with changes to other standards in the sector as well as regulations such as the European Medical Devices Regulation, the European Commission Guidelines on Good Clinical Practice and other similar guidance from the US Food and Drug Administration.
ISO 14155 was developed and updated by the WG 4 (Clinical investigations of medical devices in humans) operating as part of the ISO/TC 194 (Biological and clinical evaluation of medical devices).
Information for source: https://www.iso.org/news/ref2535.html
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International Cooperation Department
Uzstandard agency
International Cooperation Department
