It is well known that the design and conduct of a clinical investigation should be done under good clinical practice (GCP) to ensure the proper scientific conduct and the integrity of the results, and to protect the rights, safety, and well-being of the human subjects involved in the investigation. The most known GCP guideline is the ICH E6(R2), which was...
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It is well known that the design and conduct of a clinical investigation should be done under good clinical practice (GCP) to ensure the proper scientific conduct and the integrity of the results, and to protect the rights, safety, and well-being of the human subjects involved in the investigation. The most known GCP guideline is the ICH E6(R2), which was issued by the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use, however, as hinted by the organization name, this guideline focuses on clinical investigations of pharmaceutical products.
The GCP guideline for clinical investigation of medical devices is ISO 14155, which defines the state-of-the-art approach for the clinical development strategy for medical devices with the purpose of gathering, recording, analyzing, and reporting relevant data on the quality, performance, and safety of a device throughout its entire life cycle.
This course provides an overview of ISO 14155:2020 and presents practical guidance on how to implement the requirements of the standard in various types of clinical investigations of medical devices.
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