We manage your medical device’s entire lifecycle—from concept to disposal—starting wherever your project stands. We develop, design, and certify your product, then handle post-market support. Regulatory demands, patient feedback, and environmental impact shape our work. Through continuous revisions, we keep your product compliant and effective, collaborating closely with healthcare end-users—patients and providers. With post-market surveillance, we sharpen your device’s innovation and elevate patient care.
We strictly adhere to the Medical Device Regulation (MDR) throughout the entire life cycle of medical device development. This is achieved by developing a comprehensive compliance strategy and diligently adhering to it, seamlessly integrating all required steps into the medical device lifecycle. This includes managing corrective and preventive actions and verifying their effectiveness at every stage, down to the smallest detail. Our approach encompasses quality management, risk management, technical documentation, ongoing clinical evaluation, including PMCF, and ensures that we are ready for conformity assessment from day one.
At the heart of our MDR compliance strategy is a robust compliance information system that has been fully developed and approved to meet the standards of the Medical Device Regulation (MDR). This system is designed to streamline the development of medical device development and supports critical processes in the areas of quality management, risk management and stakeholder satisfaction. It ensures that customer and regulatory requirements are met while increasing satisfaction through continuous improvement and the prevention of non-conformities. The system, which is documented in our quality manual, operating procedures and work instructions, describes process flows, implementation steps and control methods, assigns responsibilities, allocates resources and defines monitoring techniques to ensure effective quality system performance throughout the organization.
We provide comprehensive services for the development, production and regulatory compliance of medical devices in the European market. Our expertise ensures a fast and seamless pathway for non-EU medical device manufacturers to comply with the EU Medical Device Regulation (MDR 2017/745) and legally market their products in the EU. We support market entry in two ways: 1. Full-cycle development, production and placement on the market – We provide contract manufacturing and regulatory support to ensure compliance throughout the product lifecycle, from design to commercialization in the EU. 2. Seamless MDR compliance and CE marking – For medical devices manufactured outside the European Union, we help to obtain CE marking by guiding manufacturers through the conformity assessment process and ensuring that all regulatory requirements are met. In addition, for non-EU manufacturers, we act as the EU Authorized Representative (EC-REP) and fulfill the MDR obligations for compliance, post-market surveillance and communication with the EU authorities.
We offer solid protection for your intellectual property (IP) throughout the development process. Until a patent is obtained, confidentiality is paramount, which we diligently enforce through non-disclosure agreements (NDAs) signed prior to any discussion. Our supply chain strategy aims to minimize intellectual property exposure by segregating product components and preventing unnecessary disclosures. We require all disclosures related to your project to be pre-approved by you, and our agreements are structured to maintain confidentiality without delay. With a streamlined NDA process and an unconditional commitment to confidentiality, we guarantee that your innovations remain secure throughout the development and manufacturing phases.