D.med Software specializes in the development of secure, compliant, and scalable software for the medical device industry. With over a decade of experience, the company supports the full product lifecycle – from embedded firmware and desktop applications to web platforms and cloud-connected systems. Their multidisciplinary team combines expertise in software engineering, regulatory compliance, and cybersecurity to help MedTech companies bring innovative products to market efficiently and safely. D.med Software ensures alignment with international standards and regulatory frameworks, including IEC 62304, IEC 60601, ISO 13485, ISO 14971, MDR, FDA 510(k), and IEC 81001-5-1.
Interview with Alejandro Torres Molina, Head of Marketing & BD at D.med Software.
What are the main areas of activity of the company? Our core activities focus on:
Alejandro Torres Molina: Development of embedded software for medical devices, providing customized solutions that ensure compliance with the most stringent regulatory standards, such as FDA and IEC 62304.
Custom Software as Medical Device (SaMD) solutions that integrate with healthcare systems, EHR platforms, and connected medical devices, enabling real-time monitoring, advanced diagnostics, and clinical decision support.
Cybersecurity and regulatory compliance, supporting manufacturers with premarket security planning, threat modeling, penetration testing, and postmarket surveillance, ensuring that connected medical technologies meet the highest standards of safety and data protection.
Medical device electronics design services tailored to the strict demands of the healthcare industry
R&D collaborations, where we contribute advanced software capabilities to European innovation programs.
What’s the news about new products/services?
A.T.M: IoMeT Connect is our latest innovation: a secure, plug-and-play connectivity platform that enables both legacy and next-generation medical devices to integrate seamlessly with cloud ecosystems and hospital IT infrastructures.
Designed specifically for the demands of modern MedTech, IoMeT Connect simplifies device integration, enables real-time data acquisition and visualization, and ensures full compliance with the latest cybersecurity and regulatory requirements (FDA, MDR, IEC standards). With its modular and scalable architecture, the platform supports multi-device environments, interoperability between systems, and flexible cloud deployment.
By handling connectivity, PKI-based security, OTA updates, and lifecycle management out of the box, IoMeT Connect helps manufacturers accelerate digital transformation, reduce time-to-market, and significantly cut development and maintenance costs.
In short, IoMeT Connect provides the secure and reliable connectivity foundation medical devices need—so manufacturers can focus on innovation, not infrastructure.
What are the ranges of products/services?
A.T.M: D.med Software offers:
- Embedded and control software for all kind of medical devices.
- Connectivity and cloud platforms, including IoMeT Connect for real-time device communication and analytics.
- Cybersecurity services, including audits, penetration tests, security architecture, and compliance consulting.
- Regulatory and quality support, helping manufacturers navigate MDR, FDA, IEC 62304, ISO 13485, and AI-related requirements.
- Custom software development for medical OEMs, including full lifecycle support from design to post-market maintenance.
What is the state of the market where you are currently active?
A.T.M: The market for digital health technologies and connected medical systems continues to grow rapidly. Manufacturers are investing heavily in reliable software, secure data architectures, and cloud-based platforms. At the same time, regulatory expectations are becoming more demanding, particularly around cybersecurity and lifecycle documentation. This creates a strong need for specialized partners capable of delivering compliant, high-quality medical software.
What can you tell us about market trends?
A.T.M: We see three major trends shaping the industry:
- Interconnectivity and cloud migration, with increasing demand for scalable connectivity platforms like IoMeT Connect.
- Growing cybersecurity requirements, driven by new standards such as IEC 81001-5-1 and the latest FDA mandates.
- Adoption of AI and predictive analytics, as health systems and manufacturers seek to leverage real-time data for optimizing treatments, managing risks, and supporting decision-making. These trends are accelerating the demand for highly specialized software engineering combined with regulatory expertise.
What are the most innovative products/services marketed?
A.T.M: Our most innovative developments include:
- IoMeT Connect, enabling secure, interoperable, and scalable integration of medical devices with cloud and clinical environments.
- Advanced cybersecurity and compliance frameworks tailored to medical software, combining threat modeling, penetration testing, and documentation aligned with global regulations.
- Next-generation dialysis software modules, optimized for safety, reliability, and real-time performance.
What estimations do you have for the end of 2025?
A.T.M: By the end of 2025, we expect significant growth in our connectivity and cloud-software segments, driven by IoMeT Connect adoption and by increasing cybersecurity and regulatory needs. We anticipate expanding our partnerships with European manufacturers and innovation programs, strengthening our role as a strategic technology provider for both medical OEMs and digital health initiatives.
