Australia and Oceania
The new article provides a brief overview of the regulatory approach towards software-based products intended to be marketed and used in Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
FDA
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...
IMDRF
The new article describes in detail the approach to be applied with respect to communication-related matters during the support stage of the total product life cycle. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), an association of...
FDA
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...
Uncategorized
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...
Uncategorized
Regulatory management is important for ensuring compliance in a variety of industries but is especially crucial for medical device manufacturers. However, regulatory information management systems for medical devices often remain behind the times and are held back by...
