We are proud to celebrate a significant milestone: the LuX-Valve Plus™, a novel Class III implantable cardiovascular device for transvenous tricuspid valve replacement, independently developed by Jenscare, has successfully achieved EU MDR CE certification.
Qserve is honored to have partnered with Jenscare Scientific throughout this important journey. Our Clinical Research Organization (CRO) and consultancy teams worked closely together to deliver comprehensive clinical and regulatory support, contributing to the successful completion of the EU multicenter clinical investigation and the final EU MDR certification. Delivering this project required navigating diverse regulatory landscapes and operational challenges across Europe.
The professionalism, dedication, and seamless collaboration demonstrated by the Qserve team earned high recognition from Jenscare. This achievement reflects our commitment to helping innovative medical device companies bring life-changing technologies to patients worldwide.
With extensive expertise in high-risk implantable and interventional medical devices, Qserve provides a complete range of clinical and regulatory services, including multicenter clinical trial management for EU MDR and FDA requirements, Clinical Evaluation Report (CER) writing, regulatory submission support, and global market access solutions.
Congratulations to the teams at Jenscare and Qserve on this outstanding achievement!
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Successfully bringing a novel, high-risk medical device to market requires a strong clinical and regulatory strategy from the earliest stages of development through certification and beyond. Whether you are preparing for an EU MDR clinical investigation, developing your regulatory submission, or planning global market access, Qserve's integrated Clinical, Regulatory, and Quality experts are here to support you at every step.
Contact Qserve today to discover how our integrated CRO and regulatory expertise can help accelerate your path to market with confidence.