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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.
ISO 13485 certification is a voluntary quality management system certification for medical device companies to meet applicable regulatory requirements.
ISO 9001 certification is a voluntary certification of the quality management system based mainly on the improvement of customer satisfaction and its processes.
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.
“Origine France Garantie” is the only certification that attests the French origin of a product.
It assures consumers of the traceability of the product by giving a clear and objective indication of its origin.
“Service France Garanti” certification enable to promote service companies employing in France. This certification is a guarantee of transparency, proximity and quality.
Since 2014, STEPHANIX holds the “Origine France Garantie” certification for its D²RS remote-controlled tables. We are the first company in the medical imaging sector to obtain this label for ours D²RS x-ray remote-controlled tables.
The certification is based on two cumulative criteria that companies must reach:
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.
In 2024, Stephanix was certified “Service France Garanti” for its after-sales service.
With almost 90 technicians throughout France, our territorial coverage ensures proximity and responsiveness to our customers.
Service France Garanti is based on two cumulative criteria that companies must meet:
This certification shows our commitment to offering to our customers, local support, provided by teams located throughout France.
For our customers, this certification is a real guarantee of quality and proximity. It enables to provide long-term support, thanks to committed local teams.
In addition to our D²RS x-ray remote controlled tables certified Origine France Garantie, this certification reinforces our commitment to promoting French know-how and maintaining local employment in the medical imaging sector.
An annual audit is carried out by an accredited organization that ensures that our products comply with the requirements of these two certifications.
Created in 2010, the goal of the Origine France Garantie certification is to defend and promote Made in France.
Created in 2020, Service France Garanti certification enable to recognizes the efforts made by companies to maintain or locate their service activities in France.
In July 2023, Stephanix was selected for a prestigious “Made in France Exhibition” from more than 2500 French companies.
Stephanix exhibited his D²RS 90/90 remote-controlled table in the prestigious Elysée Presidential Palace in Paris.
Initiated by the French President of the Republic, this annual exhibition is open to the general public for two days and highlights companies commited to French manufacturing.
In October 2023, STEPHANIX won the South-East region’s RMC 2023 PME* award in the “Made in France” category, thanks to our recognised French expertise in medical imaging with our D²RS remote-controlled table.
The RMC PME Trophies competition is the largest SME competition in France. For this 14th edition, more than 1,000 companies competed in 6 categories.
*PME (SME in English) stand for : Small and Medium-sized Enterprises
For the 3rd edition of the “Origine France Garantie” awards, the jury, composed of the Board of Directors of ProFrance, awarded STEPHANIX with the “Origine France Garantie” trophy for Export category.
In 2021, our D²RS remote-controlled tables were installed 50% abroad, and 50% in France.
The “RMC” SME Trophies have been held since 2009.
They bring together managers, the CCI and regional players to defend and promote know-how, innovation and competitiveness of French companies in France and abroad.
In September 2019, STEPHANIX is the laureate of the South-East region of the SME trophy competition in the « Made in France » category, thanks to our D²RS remote controlled table and our French know-how.
Our SME was rewarded in 2018 the Industrial Innovation Award during the “Victoires de l’Innovation Loire/Haute Loire” in France, for our remote-controlled radiology table D²RS.
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