In more than 15 years of helping our customers bring new medical devices to the market, we have built up in-house resources and developed a network of strategic suppliers and close working relationships with regulatory bodies that help us accelerate market introduction of new or next generation products. Flexible project team organizations support the integration of our own resources with customers’ project teams to leverage the combined experience and shorten project time lines.
We offer in-house engineering and regulatory expertise to support development and commercialization of complex catheter, delivery, and implant systems for a broad range of applications. We provide complete turnkey solutions for the market introduction of new products and next generation products or serve as an outsourcing partner for specific program elements, such as stand-alone regulatory services or OEM manufacturing.
Our manufacturing services range from prototyping and pilot production in our facility in Dresden, Germany to full scale, serial production in our manufacturing facility in the Czech Republic. Our team of experienced manufacturing engineers supports the timely transition from small series production to cost effective, serial production in parallel with the development and regulatory activities.