We’re building a digital health application that needs to analyse vital sign data and generate clinical alerts- and, of course, we also need MDR IIa certification. The regulatory side (documentation, quality management, audits) has been a significant bottleneck, and building a compliant analysis backend from scratch feels like a grind that can easily take 18–24 months and large costs. actimi.com

In researching approaches, I noticed that some teams are now embedding pre-certified analysis engines that handle things like:

vital parameter analysis (blood pressure, heart rate, glucose, oxygen, etc.)

patient prioritisation and clinical alerts

defined limit values and alert thresholds

For example, platforms like ACTIMI Signals are already MDR IIa–certified and can be integrated as an API for this purpose, potentially saving years of certification time and cost. actimi.com

I’m curious how others are approaching this problem in 2025–2026. Specifically:

Are you building your own analysis + alerting infrastructure?

->Are you integrating third-party solutions, and if so, what trade-offs do you see?

->How do you handle traceability, audit logs, and safety-relevant workflows?

->Would you do things differently if starting today?

Looking forward to hearing experiences from teams who have tackled regulated clinical data pipelines or similar compliance challenges.