SFDA Guidance on Surgical Sutures: Overview
The article highlights the critical points associated with the regulatory framework for surgical sutures intended to be marketed and used in Saudi Arabia.
The article highlights the critical points associated with the regulatory framework for surgical sutures intended to be marketed and used in Saudi Arabia.
The article provides a general overview of the regulatory requirements for medical devices developed by healthcare institutions to meet their internal needs.
The new article highlights the critical points associated with the concept of intended use and clarifies the approach to be applied concerning risks associated with in-house medical devices.
The Food and Drug Administration (FDA) has published detailed guidance dedicated to the use of International Standard ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. International...
ISO, the International Organization for Standardization, issued a new standard dedicated to the application of risk management to medical devices. Brief Overview of ISO standards ISO is an organization comprised of several national standards bodies. The...