The article describes in detail the approach to be applied for clinical evidence for implantable pulse generator systems and also highlights the key points to be considered in this respect, including the matters related to the scope of evidence to be provided. Table...
The new article describes in detail specific aspects related to the regulatory requirements for clinical evidence for cardiovascular devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
The new article highlights the key points related to the regulatory evidence for cardiovascular devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulatory agency in the sphere of healthcare products, has published a guidance...
The new article highlights additional aspects related to clinical evidence for joint prostheses in terms of post-market surveillance, which become especially important since such devices are intended to be used for a long period, so their long-term safety and...
The new article provides additional details regarding the requirements to be applied for clinical evidence for joint prostheses. In particular, the document describes the approach for clinical investigations to be conducted to collect clinical evidence necessary to...