HSA Draft Guidance on Clinical Evaluation: Overview
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
The new article describes in detail additional controls to be implemented with respect to medical devices that are no longer supported by their manufacturers. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary association of...
The new article highlights the aspects related to the “End of Support” stage of the total product life cycle and outlines the key points to be taken into consideration at this stage in order to ensure the proper performance of medical devices as well as the safety of...
The new article highlights the aspects related to the limited support stage of the total product life cycle and provides recommendations to be followed by the parties involved. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary...
The new article highlights the aspects related to the support stage – a period when healthcare providers use a medical device while being fully supported by its manufacturer. Table Of Contents: The International Medical Device Regulations Forum (IMDRF), a...