Build & regulate
MedTech & SaMD Architecture
Shape product intent, system boundaries, delivery controls and evidence needs before complexity hardens.
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Certified Company
Built on Standards. Driven by Innovation.
Who we are
In the dynamic MedTech landscape, we combine innovation, precision, and certified quality.
As experts in SaMD and product development, we support corporate partners in expanding their digital health portfolios. With a strong QMS foundation, we deliver visionary, compliant solutions that turn ideas into pioneering products.
Moebiusol is registered on the United Nations Global Marketplace (UNGM), supplier no. 1226866.
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MedTech System Architecture
We engineer interoperable, secure, and scalable systems that connect devices, data, and decision-making — from concept to compliance.
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Regulatory-Ready Innovation
From ISO 13485 to IEC 62304 and ISO 27001, our workflows are built with certification in mind — enabling faster market entry with confidence.
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Years
in the field
in the field
Meet our services
End-to-end services for MedTech,
software systems, and beyond
Secure architecture for SaMD platforms across mobile, web, and private cloud — privacy-first, ISO 13485 and IEC 62304 aligned.
We design embedded software and IoT ecosystems for connected medical devices — from wearables to telemedicine hubs.
We deliver software for regulated fields like aerospace, finance, and pharma — compliant by architecture and proven delivery practices.
Architecture and development of MLM–augmented, cloud, and IoT systems with complex data flows and deep analytics capabilities.
Customer satisfaction
We use a maturity and compliance framework to assess your MedTech product’s readiness for certification and deployment.
The Project Readiness Index reflects:
- Functional completeness
- Regulatory alignment (ISO 13485 / IEC 62304)
- UX/HFE and cybersecurity readiness
- System integration & scalability
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Sustainable Design Commitment
We embed eco-conscious choices into every design decision — from code efficiency to hardware selection.
Our Sustainable Design Score considers:
- Energy-efficient runtime performance
- Use of eco-certified components
- Modular, repairable architecture
Why choose us
Engineering Trust. Delivering Innovation.
We blend regulatory-grade quality with cutting-edge technology to build MedTech and digital health solutions that are secure, scalable, and future-ready. Our team bridges the gap between compliance and creativity — delivering outcomes that meet standards and exceed expectations.
Case Studies
Latest showcase and
solutions to our customers!
Open-source case study
Agentic Workstation Runtime
A governed AI engineering runtime combining MCPs, agents, skills, model teamwork, and PostgreSQL-backed memory/RAG for complex regulated work.
View case studyMeet our services
Choose the capability your difficult problem needs
Six focused engagement paths, from regulated product architecture to dependable platforms and governed agentic delivery.
Build & regulate
Software & Product Engineering
Turn architecture into dependable mobile, web and platform capability through reviewable delivery.
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Connected Medical Devices & IoT
Connect edge, application, secure data flow and operational context as one system.
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Secure Platforms & DevSecOps
Build controlled promotion, private infrastructure and recoverable operations into the platform.
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Interoperability & Data Platforms
Preserve meaning, provenance and continuity across organisational and technical boundaries.
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Governed AI & Agentic Delivery
Use agents, reusable skills and evidence-aware memory without losing accountability.
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Our Solutions
Smart. Scalable. Standards-Aligned.
Cloud-native and ISO 13485-ready, our platforms deliver precision, safety, and performance for regulated digital health products. We specialize in standalone software that meets the definition of a medical device, including clinical calculators, diagnostics, and remote monitoring.
We bridge the physical and digital with real-time, edge-to-cloud data flow for biosignals, vitals, and environmental context. Our solutions integrate seamlessly into consumer or clinical-grade wearables, enabling continuous monitoring with privacy and compliance in mind.
Compliance in Code. Clarity in Data.
Designed with clinicians and patients in mind, our UIs surface real-time health insights in clear, usable formats. Whether it's a professional monitoring console or patient companion app, we prioritize trust and clarity.
Our systems come with built-in support for ISO 13485, 14971, 62304, and 27001. We deliver traceability matrices, audit logs, documentation frameworks, and architecture rationale — ready for regulators.
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