ISO 14155
ISO 14155 is an international standard that provides guidelines for the clinical investigation of medical devices in human subjects. It outlines principles for designing, conducting, recording, and reporting clinical investigations to ensure the safety, rights, and well-being of participants, as well as the scientific validity of the data. The standard applies to all clinical investigations of medical devices, including in vitro diagnostic devices, and is essential for regulatory submissions in many countries.
Developers should learn ISO 14155 when working on software or systems for medical devices, clinical trials, or healthcare applications that involve human subjects, as it ensures compliance with regulatory requirements and ethical standards. It is critical for roles in medical device development, clinical data management, and regulatory affairs, particularly in industries like pharmaceuticals and biotechnology where safety and efficacy must be rigorously demonstrated. Use cases include designing clinical trial software, implementing data collection systems, or ensuring that development processes align with Good Clinical Practice (GCP).