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December 23, 2025
Exploring the Regulatory Framework for Medical Software: Challenges and Solutions

A well-prepared Performance Evaluation Report (PER) is essential for demonstrating the safety, effectiveness, and regulatory compliance of IVD medical devices in the Saudi market.

December 23, 2025
Exploring the Regulatory Framework for Medical Software: Challenges and Solutions

A well-prepared Performance Evaluation Report (PER) is essential for demonstrating the safety, effectiveness, and regulatory compliance of IVD medical devices in the Saudi market.

July 6, 2025
Top 6 ISO 13485 Requirements Every Medical Company Must Follow

Discover the six most critical ISO 13485 requirements that medical device companies must implement to ensure regulatory compliance, product quality, and patient safety. This guide simplifies the standard’s key elements for smooth certification and market readiness.

January 28, 2025
Understanding SFDA Requirements for Distributors of Medical Devices in Saudi Arabia

Saudi Arabian distributors play a crucial role in the healthcare supply chain, ensuring that medical devices reach the market in compliance with local regulations.

October 21, 2024
SFDA's Post-Market Clinical Follow-up (PMCF): Ensuring Medical Device Safety and Effectiveness

Post-Market Clinical Follow-up (PMCF) is a crucial aspect of maintaining the safety and effectiveness of medical devices after they have been introduced into the market.

October 13, 2024
Saudi Arabia's Unique Device Identification (UDI) Role in Medical Device Safety

SFDA has introduced stringent regulations for Saudi-DI for all medical devices marketed within the Kingdom.

August 4, 2024
Comparing SFDA’s IVD Regulatory Framework with IVDR (European Standards)

Reliable diagnostics are essential for public health, making it imperative to understand the regulatory frameworks that govern these devices.

August 1, 2024
Understanding ISO 13485: Ensuring Quality and Safety in Medical Devices

An ISO 13485 quality management system (QMS) specifies requirements for the design and manufacture of medical devices

August 1, 2024
Understanding Accuracy and Precision in IVD Devices: Implications for Safety

Modern healthcare relies heavily on in vitro diagnostic (IVD) devices to provide essential data that allows clinical decisions to be made.

July 28, 2024
Inside NCMDR: Everything You Should Know About Medical Device Reporting

Essentials of the National Medical Device Reporting (NCMDR) system, explaining its purpose and key requirements for reporting medical devices.

July 28, 2024
Classification and Registration of Medical Devices: Decoding the SFDA's Process

This outlines the Saudi FDA's classification and registration process for medical devices, offering key insights for manufacturers navigating the regulatory landscape.

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December 23, 2025
Medical Device
Exploring the Regulatory Framework for Medical Software: Challenges and Solutions

A well-prepared Performance Evaluation Report (PER) is essential for demonstrating the safety, effectiveness, and regulatory compliance of IVD medical devices in the Saudi market.

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