MedTechWare is a boutique engineering consultancy that turns bold healthcare ideas into connected, FDA-ready products. Our single team designs, builds, tests, and secures every layer of the stack: embedded firmware, custom electronics, cloud and web platforms, mobile companion apps, UX / UI, verification and validation, and cybersecurity.

Core Services:
• Class I, II, III devices
  – In Vitro Diagnostics instruments
  – Drug-delivery pumps and patch injectors
  – Patient-monitoring and imaging systems
  – Surgical robotics and therapeutic devices
  – SiMD firmware plus electronics
  – SaMD cloud and mobile platforms
• Wearables, point-of-care units, floor analyzers
• Cloud and web: serverless AWS, Azure, GCP; real-time dashboards; device telemetry pipelines
• Mobile apps: native iOS / Android and Flutter with secure BLE sync
• UX / UI: storyboarding, Figma prototypes, human-factors validation
• Premarket cybersecurity
  – Gap reviews, threat modeling, risk analysis, SBOM creation
  – Implementation of encryption, secure boot, OTA update controls
• Software testing, verification and validation
  – Automated unit and integration frameworks
  – Requirements trace matrices, FDA submission artifacts
• Regulatory guidance: DHF remediation, pre-sub support, 510(k) and De Novo software sections

Why MedTechWare

One-partner efficiency – firmware to cloud under one roof

Regulatory DNA – every artifact is audit-ready

Security by design – SBOM and controls included from day one

Speed without shortcuts – agile sprints, weekly demos, continuous integration

Choose MedTechWare and discover where software meets hardware without compromise.

MedTechWare

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