Software services for product development in regulated industries

The rise of Heaven Solutions and the natural growth of talented people in our team is the pride and core foundation of the company.

office.ro@heavensolutions.com

Delivering continuous value for industry leaders for over 20 years

The rise of Heaven Solutions and the natural growth of talented people in our team is the pride and core foundation of the company.

Let’s talk

office.ro@heavensolutions.com

Continuously acquiring top talent, due to our work culture and our people-centric approach

Let’s talk

office.ro@heavensolutions.com

EXPERIENCE · TRUST · RESULTS

We’ve been helping regulated businesses succeed for over two decades.

Medical Devices & Healthcare

  • Digital Dentistry: AI Agents, CAD/CAM, X-RAY, Functional and Digital Occlusal Analysis, Cloud integrations & Diagnostics
  • Extracorporeal Life Support Systems (ECLS), ECMO
  • Gait analysis and gait training
  • Atrial Arrhythmias: diagnostic and treatment
  • Air Ambulance by Helicopters
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Transportation & Logistics

  • Border Control & Identity Management
  • Railway Services (Infrastructure, Cargo, Kritis, Sales)
  • Air Transportation by Helicopters (Oil & Gas, Medical)
  • Ground Operations and Fleet Management
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Security & Biometrics (Border Control)

  • Border Control & Identity Management
  • Communications
  • Border Control & Identity Management
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PROVEN MEDTECH RESULTS
20+
years of regulated
software engineering
60%
faster software
verification, up to
35%
lower development
costs, up to
100 people
in Germany, Romania,
US & Malta
Experience across dental technology, electrophysiology, cardiac mapping, ECMO/ECLS, dialysis, gait analysis, implants, prosthesis & clinical diagnostics.

Experience · Trust · Results

Areas of expertise

Services

We design and deliver compliant, scalable systems - from concept to production.

01 AI Software Engineering
  • AI-optimized workflows & AI agents on-prem & cloud
  • Data engineering, analytics & data science
  • LLMs, chatbots & machine learning use cases
  • Rapid prototyping of new digital products
  • We can accommodate high agile and waterfall development
02 Verification, Validation and Quality Assurance
  • AI-augmented testing, test management, and strategies
  • AI testing agent UI-based
  • Automation, manual, and firmware testing
  • Verification against MDR/FDA and internal quality gates
03 AI Integration
  • AI-augmented enterprise application development
  • Cloud & DevOps, cloud agnostic, CI/CD
  • Embedded C/C++, HMI Qt/QML
  • Secure deployment pipelines from prototype to production
  • Integration with medical devices
04 AI Governance
  • MDR & FDA compliance, IEC 62304 & ISO 13485
  • Quality Management Systems
  • Audit and assessment support
  • Cybersecurity and risk assessments
  • Process improvement and product lifecycle support
  • Business analysis and documentation
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Opportunities for Value Creation — Heaven Solutions
End-to-end services that deliver

Opportunities for Value Creation

Accelerate Time-to-Market

Integrate AI to streamline product development processes and expand engineering, testing capacity to shorten delivery and verification cycles.

Result

Get products to market faster with fewer delays and better documentation.

Increase the number of customers!

Reduce Delivery Risk

Embed FDA, MDR, IEC 62304 and ISO 13485 expectations throughout delivery. The Cyber Resilience Act now adds cybersecurity obligations on top.

Result

Cut engineering costs by 30% while maintaining high standards and reducing project risk.

Profitability increases!

Forward Deployed Engineers and Specialized Talent

Forward Deployed Engineering Teams in MedTech experienced in AI, Data Engineering & Science, QA, DevOps and compliance-aligned.

Result

Win new clients, expand into new markets, and unlock recurring revenue streams.

Grow your company value!

Adopt AI Responsibly and Compliant

Build useful AI and Agents with clear controls for data, permissions, outputs and auditability. Ungoverned AI use is a compliance risk.

Result

Reduce inefficiencies, automate manual tasks, and improve internal alignment.

Increase user satisfaction while lowering operational costs.

AI & Data Engineering

Turning data and industry experience into better decisions

We help teams validate ideas faster, connect data sources, automate workflows, and build intelligent systems that support real business decisions.

Build and test PoCs quickly to validate ideas, reduce risk, and automate processes.

Use existing data to unlock smarter development solutions and new business potential.

Combine different data sources to obtain valuable insights across teams and systems.

Create drill-down dashboards and charts that support smarter business decisions.

We design and implement intelligent systems powered by AI, data engineering, and applied data science.

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Client voices

What our clients say

Trusted partnerships built on delivery, quality, flexibility, and long-term collaboration.

Built with industries leaders

Companies that trust us

WHY WORK WITH US

A Trusted Partner,
Not Just a Provider

01. Trusted Industry Expertise

Over 20 years of experience in highly regulated industries like Medical Devices and Healthcare. Trusted by global leaders to develop secure, high-impact R&D products.

02. Flexible & Client-Centric

We adapt to your needs—with agile collaboration models, on-site support, and a team ready to travel. Always close to our customers, always ready to deliver.

03. Security You Can Rely On

We have in place both hardware, software and processes to ensure the security of the projects we develop.

04. Growth Through Excellence

We hire top performers and invest continuously in upskilling our people. Our team members are certified and highly experienced.

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Community & Impact

We invest in people, education,
and local communities

Our work doesn’t stop at the client. We actively support educational, social, and community-driven initiatives that create long-term impact.

PIN Award event
Awards & Recognition

PIN Award 2025
PIN Award 2024 CSR

Robotics team support
Education & Technology

Robotics teams support
and performance

Scholarships for students
Students & Future Talent

Scholarships for the best
students

Contact us

Let’s talk.

We’re ready when you are. Reach out to our team and let’s discuss how we can help.