At Stella Surgical, we work every day to offer the best and most efficient solutions to satisfy our users. In a desire of transparency and excellence, the quality approach is at the heart of our concerns.
Each solution we develop are subject to a certification process. This ensure that our technologies comply with the legal requirements.
Our medical solutions :
– Are certified CE marking according to Regulation 2017/745/EU (on Medical Devices) in compliance with regulatory and legal requirements ;
– Comply with FDA (Federal Drug Agency) requirements for the US and North American market.
Our other solutions comply with European legal and regulatory requirements under the RED 2014/53/EU directive regarding the provision of radio equipment, and EMC 2014/30/EU which concerns electromagnetic compatibility.
Stella Surgical is also committed in an international ISO13485 version 2016 certification process for its quality management system.
We are committed to providing our customers with unique, innovative, and totally secure solutions to enable medical teams and organ transporters to benefit from better working conditions during each stage of the transplant process.