Transforming MedTech with Intelligence

At MIDI, we develop next-generation SaMD (Software as a Medical Device) and Medical Device solutions that leverage Artificial Intelligence (AI) and Machine Learning (ML) to accelerate innovation across digital health platforms and broader healthcare ecosystems. We are advancing patient care with technologies that enable earlier detection, more personalized therapies and streamlined workflows. We don’t just explore these possibilities we plan, design, validate and deliver them with deep technical expertise, rigorous testing and regulatory integration that medical markets demand.

Our teams balance innovation with compliance by combining data scientists, engineers, clinicians, usability experts and regulatory specialists. Every software development program is initiated in an AGILE-SCRUM development sandbox-environment then advanced beyond proof of concept into safe, reproducible and regulatory-ready solutions. From FDA and EU MDR to ISO 13485, ISO 14971 and IEC 62304, MIDI builds regulatory alignment into every stage of development through market release and beyond. Our solutions are structured to scale with the needs of our clients, from enterprise-level platforms supporting multi-state healthcare systems to specialized applications for niche clinical devices.

AI/ML is never static. Models evolve, data shifts and regulations advance. MIDI develops SaMD solutions with full lifecycle management, including continuous monitoring, performance drift detection and controlled updates. This proactive approach protects long-term performance and sustains patient and clinician trust. Backed by decades of MedTech experience, we create AI/ML solutions that combine innovation with practicality. Our programs are designed to achieve measurable outcomes while remaining reliable, transparent and regulatory-ready.