Uncategorized
Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market surveillance and risk management program, providing ongoing...
FDA
The new article describes in detail the aspects related to the applicability of recommendations provided in the guidance in terms of medical devices and regulatory pathways. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
Saudi Arabia
The new article highlights the aspects related to the requirements applicable to the entities providing medical maintenance services, and also the services in the sphere of technical consultation. Table of Contents The Saudi Food and Drug Administration (SFDA), a...
FDA
The article outlines the key points associated with the changes to software-based medical devices marketed in the US. Table of Contents The Food and Drug Administration (FDA or the Agency) has published a draft guidance document dedicated to a predetermined change...
Europe
The new article highlights the aspects related to post market activities intended to ensure continuous safety and proper performance of medical devices allowed to be marketed and used in the country. Table of Contents The Medicines and Healthcare Products Regulatory...
FDA
The new article highlights the aspects related to the matters to be addressed in the description of the device included in the submission. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
