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🔍Regulated industries have lower post-release defect rates than standard software, and there is a good reason for it – a regulated process catches problems earlier, when they’re cheaper to fix. In medical device software, a defect caught at the stage of the requirements review stage costs a fraction of what it would cost if it reached a clinical trial or, worse, a deployed device.

In standard desktop software, a crash is an inconvenience – you restart the application and continue. The bar for “acceptable” is set by user tolerance and competitive pressure.

In medical software, the bar is set by what happens when the software fails during a clinical procedure. The standard exists because the consequences of failure are categorically different.

Working under IEC 62304 and ISO 13485 changes the shape of development work – the sequence of phases, the governance around decisions, the constraints on tools and dependencies.

💬We’re happy to talk about how we approach this in our development partnerships, or to compare notes with teams building their first regulated product. We welcome your messages here:

Contact let’s getin touchcontactus hereGPS: 47.152379; 27.607338AddressRomSoft SRLRomania, IasiChimiei 2 bis, Excel Business Center, 700391GPS: 47.152379; 27.607338Reach usPhone: +40 232 266831+40 332 800 002+40 332 800 002 Email:[email protected] infoPublisher:RomSoft SRL IasiRegistered Office:Chimiei ...

Everyone has an opinion on the EU AI Act. Too strict. Not strict enough. Both at once, somehow.
Instead of taking someone else's word for it, our teammate Iulia Weingold went through it herself, and outlined five provisions that she thought were worth mentioning. While the lens is inevitably subjective, she explains why each choice made the cut. Here they are 👇🧵👇https://www.rms.ro/top-five-eu-ai-act-regulations/

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