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 13485:2016 standards, SFRI guarantees a quality management system specifically adapted to medical devices.
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 Nationale de Sécurité du Médicament (ANSM), otherwise known as the French FDA. All SFRI products must be registered and approved by the ANSM before they can be put on the market.
SFRI is also subject to strict ANSM 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.
ANSM also intervenes to ensure that all SFRI medical diagnostic equipment functions to the standards set by the French government.
ISO 13485 ENG