We’re working on a digital health project and running into the usual bottlenecks with MDR IIa — documentation, quality management, infrastructure, safety workflows, etc. I’ve recently been researching different ways teams are approaching this. Some appear to be using pre-certified platforms instead of building everything internally (Actimi is one example I came across), and I’m trying to understand whether this actually saves time or just shifts the work around. I’d love to hear from people who have:

built MDR-compliant software in-house

used pre-built frameworks or platforms

automated parts of the compliance process

or taken a hybrid approach What worked and what didn’t? What would you do differently if you were starting again in 2025–2026? Not trying to promote anything — genuinely trying to understand the current state of the ecosystem.