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.
Saudi Arabia
The article provides a general overview of the regulatory requirements for medical devices developed by healthcare institutions to meet their internal needs.
Saudi Arabia
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.
Uncategorized
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...
Uncategorized
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
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