A product partner for medical-device companies
Software as a Medical Device development, clinical integration and eQMS support. One team to bring it together.
Discuss your product See how we’ve helpedIllustrative software workflow. No patient data or client interface shown.
A full product team, or the expertise your team is missing. From first concept to launch and ongoing support, we fit around what you need.
Selected medical-software work.
We joined a medical-software team to connect AI-generated reports to hospital records, with delivery confirmation and a traceable history.
Our EMR integration experience spans Epic, Oracle Health, MEDITECH and more, backed by AWS engineering and release documentation in the client’s quality system.
Read the integration case studyWorking with the client’s team, we took an AI capability into a complete iOS and Android experience for phones and tablets.
From product design and architecture through engineering, testing and delivery, we built the application and supported its next stage.
Read the mobile product case studyIllustrative interfaces. References and engagement details available on request.
We build the software and the evidence behind it. Our work connects design controls and risk management to verification and release, within your quality system.
We’ve helped clients achieve regulatory approvals for Class II and Class III medical devices, contributing software engineering and the documentation that supports review.
Our experience spans ISO 13485 quality processes, ISO 14971 risk management and ISO/TS 24971-2:2026 guidance for machine learning in medical devices.
We put this into practice in Greenlight Guru and ins2outs, working alongside your regulatory and clinical specialists.
See how we support qualityA new product. A missing capability. A difficult next step. Let’s work out how we can help.
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