your partner from concept to market launch
Why Choose Us:
Solutions at Half the Price of US Providers
We have a complex engineering team to speed up the process.
We are experts in Nitinol cardiovascular implants.
We offer MDR compliance and CE marking consultancy.
We provide tailored solutions from ideation to testing, supported by a skilled team for rapid development. With direct access to clinical facilities and global partnerships, we conduct efficient pre-clinical and clinical studies. Our expertise includes endoscopes, resecters, catheters, nitinol implants, controllers, and generators.
Our manufacturing adapts to your needs throughout the product life cycle. We offer project-based production for new launches, batch production during growth, and advanced mass production in maturity. At each stage, we provide tailored support to optimize production, control costs, and maintain quality.
We help you obtain CE mark certification for your medical devices, starting with a Status Evaluation Audit and a customized plan. Our support includes regulatory strategy, QMS, clinical evaluation and studies, concept feasibility, design control, biocompatibility, sterilization, software, and cybersecurity.
At our US Technology Center in Carlsbad, CA, we specialize in designing and testing nitinol implants, including stents, guidewires, and heart valve components. Our expert team leverages decades of experience to develop cutting-edge implants tailored to your needs, ensuring the highest quality products.
Contact us today
Chief Operations Officer
Phone: +1 619 800 6050
Email: christine.trepanier@medres.us