Certifications & Awards

Thanks to our know-how, we have been able to conquer the French radiology market and continue our development well beyond.

Our systems are CE marked and are registered for the most part with the FDA, Health Canada and the SFDA, allowing us to sell our products in more than 100 countries and achieving 30% of our sales internationally.

In some countries, these certifications are mandatory in order to sell our products. This is notably the case in the United States and Canada where our products hold the CSA mark.

Logo certificat SGS UKAS

ISO 13485 certification is a voluntary quality management system certification for medical device companies to meet applicable regulatory requirements.

Download our ISO 13485 certification

ISO 9001 certification is a voluntary certification of the quality management system based mainly on the improvement of customer satisfaction and its processes.

Download our ISO 9001 certification

The Medical Device Single Audit Program is an international quality management systems assessment program that verifies our compliance with regulatory requirements in the following two markets:  Canada and the United States.

CSA US medical equipment logo

CSA mark guarantees that our D²RS remote controlled tables comply with American and Canadian standards.

Origine France Garantie Certification: What is it ?

Origine France Garantie” is the only certification that attests French origin of a product.

It assures consumers of the traceability of the product by giving a clear and objective indication of its origin.

STEPHANIX, a major French player in medical imaging, is the first company in its sector to obtain this label for its D²RS remote-controlled radiology tables.

FOCUS on the ORIGINE FRANCE GARANTIE label: the only “Produce in France” certification

Since 2014, STEPHANIX holds the Origine France Garantie certification for its D²RS remote-controlled tables.

The certification is based on two cumulative criteria that companies must reach:

  • between 50% and 100% of the unit cost price is French

  • the product takes its essential characteristics in France
OFG-GRIS-AVEC-NO-CERTIF---A-utiliser copie

An annual audit is carried out by an accredited organization that ensures that our products comply with the requirements of the certification.

Created in 2010, the mission of the Origine France Garantie certification is to defend and promote Made in France.

The “Origine France Garantie” label reassures customers, in fact today they no longer know exactly where the equipment is manufactured, and more and more of our customers are sensitive to the French manufacturing and production approach. This label is a marker of our company’s DNA.

Origine France Garantie label differs from other labels such as « Made In France », « Fabriqué en France ».

A product “Made In France” can be simply assembled in France with a majority of production factors (raw materials, components) coming from foreign countries.

Indeed, the indication “made in France” is issued by the customs services stipulating that the product takes the origin of the country in which it underwent its last substantial transformation.

With the massive arrival of artificial intelligence, our company is thinking about new solutions by focusing its values on French innovation. 

We have currently manufactured more than 800 D²RS remote-controlled tables (at our headquarters near Saint-Etienne, France) which are installed throughout the world.

Thanks to Produire en France, we are also eligible for hospital projects abroad financed by France.

This is a real recognition of STEPHANIX know-how and of the great expertise of our teams in the design and manufacturing of remote-controlled tables.

Trophies and Awards

2021

Guaranteed Origin France award - Antoine Veil - category “export"

For the 3rd edition of the Origine France Garantie – Antoine Veil Awards, the jury, composed of the Board of Directors of ProFrance, awarded STEPHANIX: the Origine France Garantie – Antoine Veil 2021 prize in the Export category.

To date, our D²RS remote-controlled tables are sold to nearly 50% abroad, and 50% in France.

2019

South-Est region award for the RMC SME trophies - category « Made in France »

For 10 years, driving by journalist Jean Jacques Bourdin of RMC (media group, radio and TV), the RMC – PME* Trophies have been held. 

They bring together managers, the CCI and regional players to defend and promote the know-how, innovation and competitiveness of French companies in France and abroad.

In September 2019, STEPHANIX is laureate of the SOUTH-EAST region of the RMC 2019 PME trophies competition in the « Made in France » category thanks to our D²RS remote controlled table and our French know-how.

*PME (SME in English) stand for : Small and medium-sized enterprises

2018

Victories of Innovation Loire/Haute Loire - Industrial Innovation Award

Our SME was rewarded in 2018 the industrial innovation prize during the Victoires de l’Innovation Loire/Haute Loire organized by La Tribune – Le progrès, for our remote-controlled radiology table D²RS.