Clinical investigation of medical devices is naturally highly regulated, with numerous national and regional rules and requirements that must be adhered to by manufacturers and investigators, 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.
Widely used across the industry, ISO 14155 has been revised to align with recent regulatory changes and amendments to other relevant standards. It also features a host of additional details and information designed to help protect participants in clinical trials and medical device users and to achieve sound results.
The standard safeguards the rights, safety and well-being of trial participants and includes requirements for appropriate methodology that ensures the scientific credibility of clinical data. It defines the responsibilities of sponsors and investigators and explains the role of ethics committees, regulatory authorities, safety boards and other parties involved.
Danielle Giroud, Convenor of the ISO working group of experts who developed the standard, said patient safety is always a key focus.
“We have included significantly more guidance in areas such as risk-based monitoring, quality management, study design, auditing and ethics committees,” she said.
“This means greater detail about aspects such as informed consent, vulnerable populations, data protection and statistical considerations, all of which result in a safer clinical investigation with more solid evidence.
“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 by working group WG 4, Clinical investigations of medical devices in humans, of ISO technical committee ISO/TC 194, Biological and clinical evaluation of medical devices, the secretariat of which is held by DIN, ISO’s member for Germany. It is available for purchase from your national ISO member or through the ISO Store.