Health Tech Compliance

Helping Health Tech teams navigate compliance from early design through post-market
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Supporting medical & non-medical systems, 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

🔹 Verily
🔹 Abbott
🔹 Neptune Medical
🔹 Triton Robotics
🔹 Apple Health
🔹 Alcon
🔹 PowerVision
(aquired by Alcon)

Services

Quality Systems & Analytics ‍
◾Tool implementation & configuration (Jira, Arena, Jama Connect, SAP)
◾Quality dashboard & reporting build-out (Power BI, Tableau)
◾Metrics infrastructure for QMS/CAPA/audit tracking
◾Data migration & system integration for quality workflows
Risk Compliance & Regulatory
◾ISO 14971 risk management & FMEA
◾Combination product compliance (device + pharma)
◾QMS implementation & process harmonization
◾CAPA, NC & change control
Clinical & Technical Operations
◾Clinical validation (FIH & pilot studies)
◾Cross-artifact traceability (DHF, risk, V&V, regulatory)
◾Cross-functional quality leadership for R&D
◾Legacy documentation migration
Core Design Quality & DHF Services
‍◾Design control documentation (software, hardware, combination products)
◾DHF restructuring & audit readiness
◾Traceability matrix development
◾V&V strategy & design change impact analysis‍

SYNAPSE

CXN

Synapse

CXN

Synapse

CXN

Consult  &  Network

Consulting built on partnering with health technology teams to deliver results, not just advice.
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Bringing experience across leading medical device and health technology programs to every engagement.

Whether you're a health tech team scaling your Design Controls program or navigating audit readiness, I bring the expertise and continuity to move your project forward.

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