Our Imaging and Digital Health team specializes in Imaging Software Strategy for the Digital Health sector, preparing medical devices for FDA review with a team of former FDA reviewers, scientists, and statisticians. Our expertise spans a wide range of technologies, including AI/ML, Ultrasound, and CT/MRI Devices. Our team also addresses challenges in AI/ML implementation and offers services for technologies like Image Segmentation and 3D Modeling. We provide comprehensive, strategic guidance to navigate the complex regulatory landscape and leverage the latest in digital medical technology, ensuring clients' success in the dynamic field of digital health.

The diversity of wounds makes their treatment dynamic and multifaceted, spanning simple to complex technologies. Leveraging our integrated clinical trial services, we excel in supporting the wound care technology lifecycle. We offer comprehensive support for clinical studies, providing global regulatory expertise, market access strategies, quality assurance, CRO services, healthcare compliance, and cybersecurity. Our clients in wound care and dermatology rely on our extensive services to navigate product development and commercialization, partnering closely from initial ideation to market entry, ensuring their goals are met every step of the way.

We equipped with extensive knowledge and experience, excels in navigating the complexities of biologic and combination product development. We specialize in a wide array of biologic solutions, from recombinant proteins and platelet-rich plasma to advanced drug delivery systems and tissue engineering. Recognized as industry leaders, our comprehensive services encompass global regulatory support, clinical research, market access strategies, and cybersecurity, ensuring a seamless journey from product inception to market entry. Our commitment lies in partnering closely with our clients, guiding them through each stage of development and commercialization. Driven by a passion to deliver cutting-edge medical technology to those in need, we dedicate ourselves to excellence and innovation, ensuring our clients' products make a meaningful impact.

Our team, composed of clinical, quality, and regulatory specialists, boasts extensive experience across the entire risk spectrum of surgical devices, from simple tools to groundbreaking high-risk innovations. Committed to excellence, we equip our clients with top-tier services, empowering them to achieve their goals in product development and market entry. Leveraging our global expertise, we streamline the innovation journey, ensuring swift adoption of their technologies. Our dedication is driven by the goal to deliver medical devices to those in greatest need. We are proficient in a broad range of general and plastic surgery devices, including, but not limited to, aspirators, bandages, implants, dermal fillers, and surgical instruments, demonstrating our wide-ranging expertise in the field.

With vast experience and direct insights from former FDA dental experts, we handle complex projects across various domains, including additive manufactured dental devices, bone grafts, dental implants, and orthodontic appliances, among others. Our dedication is rooted in a passion for bringing state-of-the-art dental therapies to those in need, showcasing our role as leaders in the dental healthcare sector.

Our diverse service suite covers every innovation phase, from design and pre-market development to market approval and reimbursement. Skilled in handling complex projects, we offer services tailored to IVDs, including clinical study partnerships, protocol reviews, site management, and regulatory assistance for submissions in the US and Asia. Our expertise understands regional regulations for clinical studies. As ex-FDA IVD consultants, we collaborate closely with manufacturers and pharmaceutical partners, providing pivotal guidance throughout their clinical and regulatory journeys, positioning our expertise as a key success factor for their projects.

We are committed to delivering superior regulatory, clinical, and reimbursement services, guiding clients from concept to market success in anesthesia, respiratory, sleep, and ENT device development. Our approach, aligned with the FDA's Total Product Life Cycle framework, ensures comprehensive support through design, pre-market progression, FDA approval, and market integration. With a wealth of experience in critical care and a team inclusive of former FDA experts, we excel in managing complex projects across a wide spectrum of products like airway monitoring systems, anesthesia equipment, CPAP devices, and ventilators. Our deep involvement in the critical care sector underlines our dedication to advancing medical device innovation, aiming to deliver cutting-edge solutions to improve patient care in the anesthesia, respiratory, and sleep domains.