We build, test and document software for medical devices.
Dentsply Sirona has had our engineers in its R&D since 2014. We have also worked with teams at Boston Scientific, Getinge, zebris and Ablacon. We write the code, test it against your requirements and prepare the documentation that IEC 62304 and your notified body expect to see.
- building software for regulated products
- 20years
- in Romania, Germany, Malta and the US
- 100people
- with our longest-standing clients
- 10+years
Teams we have built and tested software with
-
Claude Certified Services Partner Services partner for Anthropic's Claude. -
Microsoft Partner We build on Azure, .NET, Power BI and Microsoft Fabric. -
ISO/IEC 27001 certified Certified information security management.
Four ways we work with your R&D team
Each can run on-site with your engineers or remotely from our labs in Iași, inside your quality management system.
- 01 AI software engineering Product software, data pipelines and AI features, from the first prototype to a release your QA team signs off. Agile or waterfall, whichever your process requires. Learn more
- 02 Verification and validation Test strategy and execution from unit to system level, including firmware and hardware workflows, traced back to requirements so an auditor can follow every result. Learn more
- 03 Systems and device integration Enterprise applications, cloud and CI/CD pipelines, embedded C/C++ and Qt/QML interfaces, and the medical devices all of it has to talk to. Learn more
- 04 Regulatory and AI governance The IEC 62304 lifecycle, ISO 13485 quality processes, risk and cybersecurity assessments, and the documentation that has to be in place before an audit. Learn more
From dental CAD/CAM to ECMO consoles
Most of our work is medical device software. Our Iași facility holds more than €5 million worth of client medical equipment, which we use to test software on the devices it will run on.
- Digital dentistry CAD/CAM, X-ray, intraoral and face scans, functional and digital occlusal analysis, cloud diagnostics and AI agents.
- Extracorporeal life support Software for ECLS and ECMO systems.
- Gait analysis and training Pressure distribution measurement and gait training systems.
- Atrial arrhythmia Diagnosis and treatment of atrial arrhythmias.
- Air medical transport Software for helicopter air ambulance services.
The same team builds software for rail and air transport (Deutsche Bahn infrastructure, cargo and sales systems, helicopter operations, fleet management) and for border control and identity management.
Inside your process, under your quality system
Our engineers join your team, follow your procedures and work in your tools. They come on-site to your premises when that helps and work remotely from Iași the rest of the time.
Two ways to engage
- On-site
- Engineers embedded in your team at your premises, for as long as the project needs.
- Remote from Iași
- Delivery from our headquarters using approved processes, our labs and structured communication.
Quality and security
Heaven Solutions is ISO/IEC 27001 certified. On client projects we work inside our clients' ISO 13485 and ISO 9001 quality management systems, to the standards their products are certified against.
- IEC 62304
- ISO 13485
- EU MDR / IVDR
- FDA 510(k)
- FDA 21 CFR Part 11
- ISO/TR 80002-2
- GDPR / HIPAA
- ISO/IEC 27001
- of projects delivered on the planned timeline
- 100%
- shorter software verification with our automation
- 50%
- with our longest-standing clients
- 10+years
- growth, year over year
- 20%a year
Tests written in plain English, run by an agent
Our AI testing agent reads a test case written in natural language and executes it through the real user interface, using the screen, mouse and keyboard. No test hooks or custom drivers. Results and evidence go straight back to Jira Xray.
It supports validation as process software under the FDA's General Principles of Software Validation, ISO 13485:2016 and ISO/TR 80002-2.
How the agent worksLong relationships, in their words
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.
Heaven Solutions provides a valuable contribution to our cross-national development team. They are the strong and flexible partner we need.
Dr. Sascha SchneiderVice President Device Software Development, Dentsply SironaThe spectrum of technology stacks, programming languages and development methods is a strong plus. In our client-server technology, they always bring in fresh ideas and a constant high quality.
Ulf WillersProject Manager, R&D, Dentsply SironaThe people behind the work
Our headquarters and labs are in Iași, with offices in Malta and Kirkland, near Seattle. About 100 people work here: experienced engineers and analysts alongside younger talent we train ourselves.
Cristian Micliuc founded the company and leads it as CEO, with Bogdan Baran as CTO and Alexandra Moroianu as CFO. You will meet Oana Teslariu early on: she looks after our MedTech clients.
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