We are a passionate team that wants to help healthcare innovators get their solution in the hand of healthcare professionals and patients.
🚀 Founded by a team of former software publishers who were pioneers in France in obtaining CE marking for software under the new European Regulation MDR 2017/745.
We are entrepreneurs and former Medical Device manufacturers, recognized as the firsts in France to obtain CE marking for class IIa Software as Medical Device under MDR 2017/745.
We are pragmatic, fast and we understand the importance of cost-efficiency and being ready to access your market.
As former manufacturers, Sparta Care is the embodiment of our commitment to empower, protect and illuminate the path for digital medical device innovators 🛡️💪
From navigating the shifting sands of regulatory landscapes to embracing the agility needed in digital health product development, our story is one of turning regulatory labyrinths into highways of opportunity.
Sparta Care is also the first born of the French digital health studio
Agora Health. We work with developers and digital health entrepreneurs with a strong innovative spirit, which makes it the perfect environment to keep in touch with the ecosystem challenges.
To be CE marked as a class IIa MD under the MDR 2017/745
To produce internal audits for QMS
co-CEO
co-CEO
RAQA engineer
Or
contact us at hello@sparta.care
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