Our Expertise Across Industry

We take pride in our depth of knowledge across every element of Design Controls and Medical Device development.

Imaging & Scanning.

Often classified as Class II and Class III devices, imaging devices play a central role in healthcare decision making.

Imaging and scanning devices are the cornerstone of modern diagnostics, turning invisible health data into clear, actionable insights. From high-resolution MRI to portable ultrasound, these technologies enable earlier detection, more accurate diagnoses, and improved treatment planning. With ongoing advancements in AI and imaging resolution, they’re shaping the future of non-invasive, data-driven healthcare.

Explore our work in Imaging & Scanning.

Surgical Navigation.

Surgical navigation devices are setting a new standard for precision in the operating room, providing real-time guidance to surgeons during complex procedures. These advanced systems leverage imaging technology and AI to enhance accuracy, reduce invasiveness, and improve outcomes. By integrating data and innovation, surgical navigation is not just improving surgeries but redefining what’s possible in modern medicine.

Explore our work in Surgical Scopes.

Surgical Robotics.

Surgical robotic systems are reshaping the future of healthcare, combining human expertise with technological precision to redefine what’s possible in the operating room. These advanced systems enable surgeons to perform complex procedures with greater accuracy, minimal invasiveness, and enhanced control, leading to faster recovery times and improved patient outcomes.

Explore our work in Surgical Robotics.

Wearable Devices.

The future of healthcare is wearable. Devices that monitor real-time health data are empowering patients, driving preventative care, and reshaping chronic condition management. As technology and medicine converge, wearables are setting a new standard for smarter, more accessible healthcare.

Explore our work in Wearable Devices.

Digital Therapeutics & SaMD.

Digital therapeutics and Software as a Medical Device (SaMD) are driving a paradigm shift in healthcare by delivering evidence-based interventions directly to patients through software platforms. These innovations provide personalized treatment, track progress in real-time, and empower patients to take control of their health. By integrating seamlessly with traditional care models, they are transforming chronic disease management, mental health care, and beyond, shaping a new era of accessible, data-driven healthcare.

Explore our work in Digital Therapeutics & SaMD.

Implantable Devices.

Implantable devices are transforming medicine by delivering life-changing solutions directly within the body. From cardiac pacemakers and neurostimulators to orthopedic implants, these innovations improve quality of life, restore function, and even save lives. By combining biocompatible materials with cutting-edge technology, implantable devices are driving the future of personalized, long-term healthcare solutions.

Explore our work in Implantable Devices.

Drug Device Combination Products.

Drug-device combination products are driving innovation at the intersection of pharmaceuticals and medical devices, offering new ways to deliver therapies with precision and ease. From auto-injectors to drug-eluting stents, these products enhance treatment efficacy, improve patient adherence, and streamline care delivery. By integrating drug delivery with cutting-edge device technology, they are paving the way for personalized medicine and better health outcomes.

Explore our work in Combination Products.

AI/ML & CADe/CADx.

Leveraging AI and machine learning, Computer-Aided Detection (CADe) devices amplify clinicians’ ability to detect abnormalities with unparalleled speed and precision, from subtle fractures to early-stage cancers. By reducing diagnostic errors and enhancing workflow efficiency, CADe systems not only improve patient outcomes but also support the shift toward preventative care and early intervention. As these technologies advance, they’re laying the foundation for a smarter, more data-driven future in healthcare.

Explore our work in AI/ML and CADe devices.