Our Blogs

November 4, 2024
Understanding the Role of the Authorized Representative (AR) in Medical Device Registration

Authorized Representatives (ARs) play an important role in the regulatory process. Medical device industry professionals or those looking to launch products in new markets

November 4, 2024
Understanding the Role of the Authorized Representative (AR) in Medical Device Registration

Authorized Representatives (ARs) play an important role in the regulatory process. Medical device industry professionals or those looking to launch products in new markets

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.

September 25, 2024
Understanding Self-Test Devices: A Growing Trend in Healthcare

Self-testing devices, also known as home diagnostic devices, allow individuals to perform health tests on themselves, interpret the results, and take action based on the results.

September 17, 2024
Role of Audit Reports and SOPs in a Quality Management System

Standard Operating Procedures (SOPs) and audit reports are two of these critical components. By working together, they ensure compliance with best practices, compliance with regulatory requirements, and continuous improvement within the organization.

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.

Bio-Standards Blog

Here you’ll find the latest blogs about compliance news and guidance for all medical industries.

November 12, 2024
Medical Device
Understanding the Role of the Authorized Representative (AR) in Medical Device Registration

Authorized Representatives (ARs) play an important role in the regulatory process. Medical device industry professionals or those looking to launch products in new markets

Latest blog posts

November 4, 2024
Understanding the Role of the Authorized Representative (AR) in Medical Device Registration
Medical Device
October 21, 2024
SFDA's Post-Market Clinical Follow-up (PMCF): Ensuring Medical Device Safety and Effectiveness
Medical Device
October 13, 2024
Saudi Arabia's Unique Device Identification (UDI) Role in Medical Device Safety
Medical Device
September 25, 2024
Understanding Self-Test Devices: A Growing Trend in Healthcare
Medical Device
September 17, 2024
Role of Audit Reports and SOPs in a Quality Management System
Medical Device
August 4, 2024
Comparing SFDA’s IVD Regulatory Framework with IVDR (European Standards)
Medical Device