The RCTs‘ Medical Devices (MDs) Regulatory team reflects on its collaboration with Novastep, now part of Enovis Foot & Ankle, a manufacturer of orthopedic medical devices.
We are proud to have supported Novastep in bringing into conformity their clinical evaluations (CEPs and CERs) on implantable DMs with European Regulation 2017/745.
Throughout this partnership, two evaluation strategies were used: leverage of own clinical data (clinical studies) and Well-Established Technology (WET) strategy.
The result: 6 technical documentation files with a clinical part validated by the Notified Body.
We would like to warmly thank Novastep for their trust in our regulatory expertise and for continuing to collaborate with us on evaluation updates.
Congratulations to our experts on their success!
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