The article provides an overview of the regulatory requirements related to radiological devices and certain aspects associated thereto. Table of Contents The Food and Drugs Administration (FDA or the Agency), the US regulating...
The article provides an overview of the regulatory requirements related to tissue containment systems. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
The new article describes in detail specific aspects of electromagnetic compatibility, including the ones related to modifications and labeling. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
The article provides an overview of the existing regulatory framework for heater-cooler devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
The article highlights specific aspects related to electromagnetic compatibility, including the ones associated with testing the products should undergo to ensure compliance with the respective requirements. Table of Contents The...