About Bio-Standards

Introduction

Bio-Standards is a consultancy firm in Medical Device Sector, specialized in regulatory affairs of the Saudi Food & Drug Authority (SFDA) and local distributor search services.  Bio-Standards was established adhering to the SFDA laws and Medical Device regulations. Bio-Standards offers you a wide range of services in the Medical Device Sector.

We provide the professional experience and the practical expertise in helping the healthcare organizations with their Saudi compliance strategy and inquiries.

Our team members understand SFDA regulations of Medical Devices & in-vitro diagnostics in detail and are very much skilled at working cooperatively with the SFDA staff to overcome difficult challenges. This approach enables us to create comprehensive solutions for all the relevant parties to comply with the Saudi Arabian Regulations or assist them to enter this niche market.

Bio-Standards handle all the sensitive tasks to their maximum intensities with professional integrity, accuracy, and transparency. Our team at Bio-Standards has extensive experience of regulatory affairs of Saudi Arabia. Our expertise is in the Medical Device Sector Regulations and we strictly do not involve in any commercial activities such as distribution/sales agent of Medical Devices.

Now partners with a worldwide leading medical device consultancy group, you don’t need to shop around for your Medical Device regulatory upkeep in Saudi Arabia and regulatory approvals from any of the five GHTF founding member’s countries (Japan, Australia, Canada, Europe & USA).

 

Our Vision And Mission

Our Vision is to be the leading medical device consultancy firm and regulatory affairs experts in the Kingdom of Saudi Arabia.

Our Mission is to expedite and facilitate the access of International Medical Device & IVD manufacturers to the Saudi Market and meet specific local regulations and requirements with integrity and perfection.