Software for medical devices, from R&D to release
Healthcare has fewer clinicians than it needs and more data than it can use, and every new tool has to fit a clinical workflow and pass regulatory review. We help device manufacturers build that software, verify it and document it for MDR and FDA.
Products our engineers have worked on
- Digital dentistry AI agents, CAD/CAM, X-ray, functional and digital occlusal analysis, face scans, cloud integrations and diagnostics.
- Extracorporeal life support ECLS and extracorporeal membrane oxygenation (ECMO) systems.
- Gait analysis and training Gait analysis, gait training and pressure distribution measurement.
- Atrial arrhythmia Diagnosis and treatment of atrial arrhythmias.
- Air medical transport Air ambulance services by helicopter.
- Digital health Backend services for an AI-powered medical chatbot, e-health apps and elderly care research platforms.
What our clients are dealing with
- 01
Too few people
Demand for skilled clinicians and engineers outpaces supply, so software has to take work off people instead of adding to it.
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Too much data
Devices and systems produce large volumes of data that are hard to turn into decisions.
- 03
Integration and compliance
New technology has to fit clinical workflows, protect patient data and meet MDR, FDA, GDPR and HIPAA requirements.
What we bring
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AI testing agents
Automated, workflow-validated test execution with evidence ready for regulated medical software.
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Engineering depth
Software for diagnostic equipment, treatment platforms and the data management around them.
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Regulatory knowledge
IEC 62304, ISO 13485, EU MDR and IVDR, FDA, GDPR and HIPAA, applied in day-to-day engineering work.
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Designed around clinical work
Interfaces and workflows that match how medical staff actually work.
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Nearshore delivery
Teams in Romania, in a European time zone, with engineers on-site when the project needs it.
Partnering with Heaven Solutions for software development, testing and engineering support on our medical device projects has been exceptional. Their flexibility and dedication ensured all deadlines were met, leading to multiple successful 510(k) and CE-marked releases. The team's friendly and respectful approach fostered a deep, trusting business relationship.
In the beginning of 2014, we started a collaboration with Heaven Solutions as we wanted to boost our in-house R&D capacity in software development as well as improve our software testing procedures. Heaven Solutions engaged with our operations both on-site and remotely. Their reliable and skilled specialists integrated themselves very well in our business culture, adding value to our internal team and allowing our department to optimize project execution.
Ulrich OrthHead of CAD/CAM R&D, Dentsply SironaI have been working with Heaven Solutions in the Active Life research project, an elderly care initiative of Aalto University, VTT Finland and various Finnish medical and IoT companies. Heaven Solutions was involved in medical services platform integrations and behavioral analysis.
Clients in this field
Relevant services
Tell us what you are building.
A 30-minute call with Cristian or Oana. We ask about your product, timeline and regulatory situation, and talk through how we could help.
Cristian Micliuc, CEO and founder
Oana Teslariu, Customer success, MedTech