Health Tech Compliance

Helping Health Tech teams bridge gaps from early design through FDA submission
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Supporting medical device, SaMD, robotics, and combination product programs from concept through commercialization. We help health technology teams navigate the full spectrum of Design Controls— delivering audit-ready compliance at every stage of development.
Clients

🔹 Johnson & Johnson MedTech / Auris
🔹 Verily
🔹 Abbott
🔹 BD
🔹 Intuitive Surgical
🔹 Medtronic
🔹 Neptune Medical
🔹 Triton Robotics
🔹 Apple Health
🔹 Alcon
🔹 PowerVision
(aquired by Alcon)

Services

Core Design Quality & DHF Services
◾ Design control documentation across hardware, software, and combination products
◾ DHF restructuring, remediation, and audit readiness
◾ End-to-end traceability matrix development and linkage analysis
◾ Design change assessment and impact analysis
◾ Verification & validation strategy development
◾ Requirements decomposition, traceability and relational database management support
Risk, Compliance, & Regulatory
◾ ISO 14971 risk management and FMEA facilitation
◾ Combination product quality support (device + pharma integration)
◾ FDA-ready quality systems and compliance documentation
◾ Usability engineering and human factors validatione
◾ QMS implementation and process harmonization
◾ CAPA, NC, and change control workflow support
Clinical & Technical Operations
◾ Clinical validation support for FIH and pilot studies
◾ Traceability support across DHF, risk, V&V, and regulatory artifacts
◾ Cross-functional quality leadership for R&D teams
◾ Relational database and requirements management support
◾ Legacy documentation migration and structure optimization
◾ Supplier and development lifecycle quality support

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