Used for a wide range of treatments in various specialized fields, active medical devices represent a significant and profitable segment of the healthcare industry. As a manufacturer of active medical devices, one of your biggest challenges in breaking into, or continuing your success in, this market is navigating the regulatory process efficiently. Strong, statistically relevant clinical data demonstrating the safety and performance of your device is essential to ensuring a successful outcome of your MDR application.
Our Active Technical and Clinical Specialists have a broad range of industry and regulatory experience, including product design and development, manufacturing and testing. They will support you through the process of certifying your device. We are experienced in working with manufacturers of ablation devices, body-worn sensors, hearing aids, infusion pumps, ventilators, software devices, surgical robots and lasers as well as, radiation therapy, ultrasound and x-ray machines and many others.