The new article highlights the aspects related to the concept of commercial availability, problematic assembly situations, and temporary installations (for instance, in case one of the existing components needs to be repaired). Table of Contents The Food and Drug...
The new article addresses the aspects related to the accessories and components of diagnostic x-ray equipment, including the approach to be applied with respect to compatibility matters. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
The new article highlights the aspects related to management review, as well as the requirements for personnel, premises, and cleanliness as set forth by the draft regulation on criteria and good methods for distributing medical devices. Table of Contents The Thai...
The new article describes the aspects related to the use of electronic form in certain aspects associated with clinical trials. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
The new article describes in detail the regulatory approach the authority intends to apply with respect to x-ray equipment in terms of assembly in order to ensure the safety and proper operations of the devices. Table of Contents The Food and Drug Administration (FDA...