Quality

At Stella Surgical, we are guided by our values of performance, quality, and integrity. Transparency and excellence are at the heart of our concerns.

We work every day to provide the best thought out and most effective solution to best satisfy our users. We are committed to the highest level of ethical standards.

All the solutions we develop are subject to a certification process. This will ensure that our technologies comply with the legal and regulatory requirements requested. We deliver what we promise.

E-graft

Our E-GRAFT solution is certified for CE marking according to Regulation 2017/745/UE (relating to Medical Devices), complies with European legal and regulatory requirements under RED 2014/53/UE for the provision of radio equipment and CEM 2014/30/UE for electromagnetic compatibility.

E-stella

Our E-STELLA solution is thus currently being certified for CE marking according to Regulation 2017/745/UE (relating to Medical Devices) in accordance with regulatory and legal requirements; as well as the requirements of the FDA (Federal Drug Agency) for the American and North American markets.

Stella Surgical

Stella Surgical has also embarked on an international ISO13485 2016 Quality Management System certification process.

In this way, we are committed to providing our clients with unique, innovative, and completely secure solutions to enable medical teams and organ transporters to benefit from better working conditions at every stage of transplantation.
It is for these reasons that our partners trust us.

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