The new article highlights the key points related to the reports of prior investigation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
The present article describes in detail the regulatory approach to be applied concerning clinical evidence related to custom-made medical devices and also highlights certain other aspects related to clinical evidence submitted in the context of applying for marketing...
The new article describes in detail the regulatory requirements to be applied for clinical evidence for adaptable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products,...
The new article describes in detail specific aspects to be considered for clinical evidence to be submitted for patient-matched medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulatory agency in the sphere of healthcare...
The new article describes in detail the regulatory approach to be applied concerning patient-matched medical devices in general and to the design envelope in particular. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulatory agency in...