Our specialized fiber optic solutions deliver precise light distribution for a comprehensive range of PDT applications. We serve multiple medical specialties including urology (prostate and upper urinary tract), head and neck procedures, gastroenterology (esophagus, bile duct, and pancreas), pulmonary treatments, and neurosurgery. Engineered for versatility and precision, our fiber optics seamlessly integrate with all major PDT laser systems and standard endoscopes. Each device features uniform light distribution and includes radio markers for superior CT visibility, ensuring precise positioning during procedures. Many of our diffusors carry CE marking, while others are advancing through clinical approval studies in Europe and the United States, demonstrating our commitment to expanding therapeutic options. Experience the next generation of PDT technology with our medical-grade fiber optic solutions.
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Fiber optics play a pivotal role in modern biomedical laboratories, offering precise and efficient solutions for a variety of applications. They enable illumination of tissue with unmatched accuracy, ensuring optimal lighting conditions during microscopic analysis and surgical procedures. By integrating advanced optical diagnostic technologies, fiber optics facilitate the detection and monitoring of biological processes in real time. Paired with LED technology, they deliver high-intensity, stable light sources that enhance imaging quality while minimizing heat generation. Compact, flexible, and reliable, fiber optics empower researchers and clinicians to push the boundaries of medical science, setting new standards in innovation and precision.
Contact our technical team to discuss your custom fiber optic needs.
We provide end-to-end management of clinical studies across Europe, from site evaluation and study initiation to full project completion. Our expertise includes thorough site assessment, study preparation, on-site technical support, and comprehensive documentation development. We handle all ethics committee applications, coordinate with local authorities, and provide complete project management oversight. Our extensive clinical research experience spans multiple medical fields, including oncology, urology, phlebology, dentistry, and photodynamic therapy (PDT). We excel in protocol development, regulatory compliance, and clinical documentation preparation, including protocols, synopses, and manuals. Partner with us to ensure your clinical studies meet the highest scientific and regulatory standards while maintaining efficient execution. Our dedicated team supports you at every stage, from initial planning through successful completion. Contact our clinical research team to discuss how we can advance your study objectives.
We guide manufacturers through every aspect of medical device certification and development. Our comprehensive certification support includes CE marking for European markets (2017/745/EU), FDA 510k submissions for US market access, and implementation of ISO 13485 quality management systems. For smaller companies, we offer dedicated quality management representation to ensure continuous compliance. Our development expertise encompasses the complete lifecycle of medical devices, with particular focus on medical lasers, fiber optics, and clinical applications. We manage all aspects of the development process in accordance with ISO 13485 standards, incorporating robust risk management practices (ISO 14971) and thorough risk analysis. Our team conducts clinical evaluations following MedDev 2.7.1 rev. 4 guidelines, ensuring your devices meet all regulatory requirements. From initial concept through final certification, our project management expertise ensures efficient development while maintaining the highest quality and safety standards. Partner with us to transform your medical device innovations into certified, market-ready solutions. Contact our certification team to discuss your development and regulatory needs.