ISO 14155 Standard Test for Clinical Research of Medical Devices and Good Clinical Practice for Human Subjects

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 14155 testing. This standard addresses good clinical practice for the design, conduct, recording and reporting of clinical trials conducted in human subjects to evaluate the clinical performance or efficacy and safety of medical devices.

For post-marketing clinical trials, the principles set out in this document are intended to be followed to the extent relevant, taking into account the nature of the clinical trial.

This standard specifies the general requirements intended:

• To protect the rights, safety and well-being of human subjects;
• To ensure the scientific conduct of clinical research and the reliability of clinical research results;
• Define the responsibilities of the sponsor and principal investigator;
• Assisting sponsors, researchers, ethics committees, regulatory authorities and other organizations involved in the conformity assessment of medical devices.

Users of this standard should consider whether other standards or national requirements also apply to the investigational devices or clinical investigation under consideration. If there are differences in requirements, the strictest will apply.

For software as a medical device, the clinical performance of SaMD applies to the demonstration of analytical validity and, where appropriate, scientific validity, to the extent that the requirements of this standard are relevant.

This standard does not apply to in vitro diagnostic medical devices. However, depending on the device and national or regional requirements, there may be situations where users of this document may evaluate whether certain parts or requirements of this document are applicable.

EUROLAB assists manufacturers with ISO 14155 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.