MedTechWare

About MedTechWare

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.

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