Industry
Healthcare
Technologies
MySQL, AWS, Java, Spring Boot, Angular
About Our Client
The client is a European MedTech startup developing precision diagnostic solutions for genetic and infectious diseases. As they prepared to enter the EU market, they needed a robust diagnostics software platform that not only supported clinical workflows but also complied with CE marking regulations and ISO 13485 standards.
Challenge
To meet stringent EU requirements, the client needed to build a diagnostics platform that was fully CE-marking compliant, with traceable testing processes, secure data handling, and built-in audit capabilities. They lacked in-house expertise in regulatory-aligned software architecture and were on a tight timeline for certification and launch.
Solution
Celestial Infosoft provided end-to-end software consulting and development support, from regulatory planning through delivery. We advised on the tech stack aligned with ISO 13485 and CE-marking readiness, then architected the system for modular functionality, secure integrations, and audit traceability.
The application was developed using Java and Angular with full traceability matrices, built-in QA workflows, and HL7-based interoperability. Our team worked closely with the client’s regulatory advisors to ensure smooth documentation and validation processes for CE certification.
Project Highlights
- Developed clinical-grade diagnostics software in just 7 months
- Ensured full compliance with CE marking and ISO 13485 software standards
- Implemented automated QA testing and traceability tools for audit readiness
- Enabled interoperability with lab devices via HL7 standards
- Integrated secure patient and clinician portals with real-time reporting
Results
- Client successfully achieved CE certification on the first attempt
- Reduced time-to-market by 40% through guided compliance consulting
- Positioned the platform for scalable rollout across EU labs and clinics
- Enhanced clinician trust with reliable, transparent diagnostic reporting
Technologies and Tools
- Frontend: Angular
- Backend: Java, Spring Boot
- Database: MySQL
- Cloud Infrastructure: AWS
- Integration: HL7
- Compliance Tools: Traceability Matrix, Automated Test Logs, Risk Management Toolkit
Client Feedback
“We came to Celestial Infosoft for software expertise, but gained so much more. Their understanding of CE and ISO compliance, combined with strong technical delivery, helped us launch faster and with confidence.”
– Client Says
