In this article, we will provide a comprehensive introduction to Class III medical devices, including what they are, how they are regulated, and what makes them different from other classifications. Whether you are a healthcare professional or simply interested in...
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents Class II medical devices are an important segment of the medical device industry.These moderate-risk devices include many...
The new article highlights the aspects related to compensation for participation in a clinical investigation, contact details to be communicated by study participants, and also the voluntary nature of participation and subjects’ rights associated thereto. Table...
The new article highlights the aspects related to the marketing applications related to the products incorporating software submitted under the various legal frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...