Our Commitment to Building the Best Quality Products for In Vitro Diagnostics

In today’s highly regulated market, IVD products must answer to various quality, security and performance requirements, guaranteeing the safety of medical professionals and patients alike.

 

At SFRI, expert teams of scientists are dedicated to ensuring that all products respect the norms and quality standards set out in our Quality Management Chart.

 

We are also committed to complying with local, regional and international corporate regulations and standards as well as product directives to ensure clients receive the best quality products and services available.

ISO Certifications

SFRI has adopted strict quality management systems by registering with the International Organization for Standardization. By adhering to ISO 9001:2000 and ISO 13485:2003 standards, SFRI guarantees a quality management system specifically adapted to medical devices.

ISO Certificate 9001-13485 English/Français
Certificats ISO 9001ISO 13485 2014_2017.[...]
Document Adobe Acrobat [158.7 KB]
ISO Certificate 9001-13485 English / SAS
ISO 9001 13 485 Anglais SAS.pdf
Document Adobe Acrobat [338.1 KB]

CE Mark

The CE mark is a mandatory conformity mark that must be affixed to all reagents and instruments manufactured in Europe as stipulated by the directive 98/79/CE. By affixing the CE mark we, at SFRI, assert that all of our products meet the essential requirements of the relevant European directives on health, safety and environmental protection.

ANSM (French FDA) Regulations and Inspections

In France, all medical devices are placed under the control of the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), otherwise known as the French FDA. All SFRI products must be registered and approved by AFSSAPS before they can be put on the market.

 

SFRI is also subject to strict AFSSAPS inspections designed to not only ensure that the company adheres to the French standards of quality, security and health but also to guarantee its compliance with the strict regulation on corporate vigilance, traceability and responsibility.

 

AFSSAPS also intervenes to ensure that all SFRI medical diagnostic equipment functions to the standards set by the French government.