Cybersecure development and postmarket support
Decades of medical device experience (it's all we do)
Design for manufacturing, quality, and testability
Every discipline, on-shore and
in-house
Design Controls & DHF curation, Risk Management, Device Integration, Verification & Compliance Testing, Support for pre/clinical studies, Support of Device submissions.
Conforming to the October 2023 FDA guidance.
Formative studies and design validation.
Custom software medical devices. iOS & Android (native and cross platform).
Power management, microelectronics, circuit design & PCB layout
Efficient, low power design. Firmware over the air update (FOTA). IEC 62304 Class A, B, C.
Industrial design, tolerance stack-up, rapid prototyping, materials selection, molds & micro-molding.
Power transfer, antenna design, and communications (BLE, MedRadio, Inductive, proprietary protocols)
Meet Our Experts
Consulting and engineering solutions for "impossible" tech. Helping you turn apparent sci-fi into life-changing reality.
Safe. Secure. Effective.
One stop for secure Medical Device R&D, product development, contract
manufacturing, and postmarket services
Who We Are
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