The new article highlights the aspects related to the classification rules to be applied with respect to invasive medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), a country’s agency responsible for ensuring the safety...
The new article highlights the aspects related to be taken into consideration with respect to the classification of active medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), a country’s regulatory agency in the sphere...
The new article highlights the aspects related to the labeling for new assay-instrument combinations, and also to the way the information about them should be added to a public database. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
The new article highlights the aspects related to the documenting requirements, as well as to the concept of an instrument family and the way it should be applied in the context of using an assay with an instrument from a different family. Table of Contents The Food...
The new article provides a brief overview of the new guidance document dedicated to the Q-Submission Program. 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...
Technology has the power to streamline redundant processes. Then, why does regulatory compliance for medical technology and devices remain mostly manual and tedious? RegDesk, a leading Regulatory Information Management System (RIMS) platform, is on a mission to...