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Scaling SaMD solutions:
Heart for Health’s journey to MDR compliance
Industry
Healthcare & Life Sciences
Service Line
Regulatory Consulting
Context
Heart for Health is a Netherlands-based innovator in cardiovascular care, developing software-as-a-medical-device (SaMD) solutions that support providers and improve patient outcomes. With the shift from MDD to MDR across the EU, they needed to overhaul their compliance framework – without disrupting their operations or growth plans.
Having partnered with us previously, they turned again to Star for regulatory expertise and a strategic, scalable approach.
Impact
Working with Star, Heart for Health successfully:
- Transitioned from EU MDD to EU MDR compliance, passing two rounds of certification audits without any nonconformities.
- Streamlined compliance processes using Star’s ins2outs system, tailored to the EU MDR requirements.
- Reduced regulatory burden by optimizing product architecture to differentiate between medical and non-medical components of the software.
This positioned Heart for Health to meet immediate compliance needs while preparing for international growth with a scalable, future-proof QMS.
Journey
The transition from EU MDD to EU MDR required a structured, expertise-driven approach to achieve compliance while minimizing disruption. Our strategy focused on:
- Defining regulatory strategy for the EU market.
- Refining Heart for Health’s QMS to align with EU MDR requirements.
- Developing tailored technical documentation, ensuring compliance for all products.
- Optimizing system architecture to reduce unnecessary regulatory obligations.
The goal was not only to meet immediate certification milestones but also to future-proof Heart for Health’s systems with a scalable QMS, ensuring ongoing compliance and supporting global market growth.
“Star’s expertise has been invaluable in helping us achieve MDR compliance. Their strategic approach streamlined our processes without disrupting our operations. With their guidance, we’re now positioned to scale confidently into new markets.”
Borut Stavrov, CTO, Heart for Health
Streamlining the QMS
Rather than rebuilding, we refined their existing QMS – embedding risk management and continuous improvement into a lean, audit-ready system, and ensuring all the additional processes required by new EU MDR were impelemented.
Precision documentation
We co-developed MDR-compliant documentation – including regulatory, test, verification and validation strategies, software architecture and specifications, risk assessments and test execution and reporting – all tailored to their SaMD products and regulatory requirements.
Optimized architecture
To reduce complexity of the post-market maintenance of the product, we reclassified mobile apps as standalone components – simplifying the regulatory scope and easing operational overhead.
What’s next
Heart for Health continues to push the boundaries of cardiovascular care. With a solid compliance foundation and strategic architecture, they’re ready to scale internationally and deliver even greater impact. We’re proud to support them on this journey.
