Digital Solutions
Software as Medical Devices (SaMD)
Digital health is reshaping global healthcare, and software now plays a central role in diagnostics, patient management, and clinical decision-making. At Simon MedTech Solutions, we support manufacturers, startups, and healthcare innovators in bringing compliant, secure, and market-ready digital solutions to Africa, the Middle East, and international markets.
As a developer and producer of our own SaMD, we understand the full lifecycle of digital medical technologies from concept to commercialization — and we leverage this expertise to support your projects with precision and efficiency.
Our capabilities cover Software as a Medical Device (SaM D), embedded medical software, mobile health applications, cloud platforms, AI-powered tools, and digital therapeutic solutions.
Our Services
We deliver end-to-end digital innovations—from tailored software development to full regulatory support—empowering healthcare providers and manufacturers with secure, compliant, and high-performance solutions
Software Classification & Regulatory Strategy
We assess your product and define the correct regulatory pathway, ensuring smooth and predictable approvals.
Technical Documentation for Software
We prepare or review architecture, risk analysis, validation files, cybersecurity requirements, and clinical evaluation inputs.
SaMD Registration & Market Authorization
We manage the full submission process in regulated markets and act as your local representative when required
Cybersecurity & Data Protection Compliance
We ensure compliance with secure design principles, data protection laws, encryption protocols, and national hosting requirements.
AI & Algorithm Transparency Support
We help you structure performance metrics, risk controls, and validation processes for AI-driven systems
Software Lifecycle & Quality Support
We support compliance with IEC 62304, ISO 14971, IEC 82304-1, cybersecurity frameworks, and IMDRF best practices.
Digital Product Maintenance & Change Management
We help build safe update cycles, patch management, and ongoing compliance mechanisms.
Hosting, Cloud & Data Localization Compliance
We guide you through local hosting obligations, secure architectures, and interoperability requirements.
Additional Digital Services
UX/UI and labelling review, Software validation and gap assessments, Vendor qualification and audits, Support for digital clinical trials and real-world data API and interoperability checks
Our products
As a digital health innovator, Simon MedTech Solutions designs, develops, validates, and commercializes its own Software as a Medical Device portfolio. Our products are built to meet international standards, with a strong focus on: Patient safety and data protection, Clinical performance and reliability, Cybersecure cloud infrastructures, Seamless integration with healthcare systems, Continuous lifecycle updates and post-market monitoring.
We market our SaMD solutions across EU, Africa, the Middle East, and select global markets, ensuring compliance with national regulatory requirements.
Get Started With Us
We’re here to accelerate your digital health journey.
Reach out to learn how we can support your regulatory, technical, or market entry strategy—or to discover our proprietary SaMD products.
Contact us today to begin.
