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Medical Devices

Clinical evaluation, evidence generation, AI and regulatory strategy for devices — including software as a medical device.

Overview

What CAD CARE brings to medtech

Clinical evaluation, evidence generation, AI and regulatory strategy for devices — including software as a medical device.

Capabilities applied here

  • Clinical evaluation plans & reports
  • Post-market clinical follow-up
  • SaMD strategy
  • AI/ML regulatory strategy
  • Usability & human factors evidence
  • Interoperability with hospital systems

Also relevant

  • Terminology intelligence
  • Vendor-neutral architecture
  • Responsible AI governance
  • Data protection by design
MedTech — typical pathDeviceconceptClinicalevaluationRegulatoryclearancePost-marketevidenceMEDTECH — TYPICAL PATH

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Why this combination

Research, technology and evidence in one place

MedTech programmes usually split these across three vendors — a CRO, a systems integrator and a strategy consultancy — who rarely talk to each other. CAD CARE holds all three, so the evidence strategy and the architecture are designed together.

If we would not be willing to implement it, we do not recommend it.

Talk about a medtech programme.

Tell us the problem and the stage you're at — research, build, validate or scale.

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