Medical Software Archives

From First Project to Primary R&D Partner

How a single laboratory management contract in 2001 grew into a 25-year strategic partnership, with RomSoft becoming Sysmex Europe's main external engineering center across 20+ products and multiple software domains. Sections in this article: The Context | Why ...

2 days ago, posted by Sebastian Dumitrescu

Diagram of an IEC 62304 compliant workflow: discovery, procedure approval, tool validation, and change-controlled implementation

What IEC 62304 compliance actually looks like inside a development team

The first question people from outside the medical device industry usually ask is: does working under IEC 62304 and ISO 13485 standards slow you down? It’s the wrong question – but it’s understandable. The right question is: how does the regulated process change ...

1 month ago, posted by Simona Vizniuc

Contrast media injector console architecture

Full software rewrite for a Class C medical device

When a German-based medical device manufacturer needed to replace 15-year-old software running its contrast media injector, the stakes went well beyond a routine rewrite. The device delivers contrast solution directly into patients during CT scans – a context where

3 months ago, posted by Simona Vizniuc

Product discovery: what teaching digitization to medical practices has taught us

In 2024, through the EDIH-DIZ project, RomSoft took on a role in what's called a "test before invest" stage: our job was to show medical clinics what digitization actually looks like in practice. Online appointments, virtual consultations, electronic patient ...

3 months ago, posted by Lucian Nita

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digitalstories

From First Project to Primary R&D Partner

What IEC 62304 compliance actually looks like inside a development team

Full software rewrite for a Class C medical device

Product discovery: what teaching digitization to medical practices has taught us

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