Medizinische Geräte und Biowissenschaften

LTTS offers end-to-end medical device engineering across five areas: digital health, device and sustenance engineering, quality assurance and regulatory affairs (QARA), digital manufacturing, and AI in MedTech. We support OEMs from concept and design through verification, regulatory submission, manufacturing transfer and post-market. The goal is simple: faster time to market, lower operating cost and compliance built in, backed by more than 200 co-authored patents in medical technology.

Software as a Medical Device (SaMD) is software that performs a medical function, such as diagnosis or monitoring, without being part of a hardware device. It is developed under a regulated lifecycle, typically following IEC 62304, ISO 14971 for risk and IEC 62366 for usability. Validation proves the software meets its intended use. For AI-based SaMD, validation also covers data quality and model performance. LTTS brings hands-on experience from AI diagnostics such as Digital Twin, Visualization framework , Gesture control and Chest-rAi™.

LTTS helps manufacturers meet EU MDR and IVDR requirements through gap assessments, technical documentation support and EUDAMED UDI registration. For post-market surveillance, we run PMS and post-market follow-up, complaint handling, vigilance reporting, trend analysis and field actions such as recalls. The difference is closing the loop: we feed post-market data back into design, risk and quality decisions instead of treating it as a periodic reporting exercise.

Treat cybersecurity as a lifecycle discipline, not a pre-launch check. In design, that means threat modelling, security risk assessment, secure architecture and a software bill of materials (SBOM). Before release, it means security and penetration testing. After launch, it means vulnerability monitoring and timely patching. The FDA now expects this evidence in premarket submissions for cyber devices. LTTS builds these practices into your existing design control and quality processes.

LTTS supports the full device lifecycle with one engineering partner. In development, our teams cover system architecture, hardware, embedded software, mechanical design, usability, and verification and validation, with design history documentation built in from day one. In sustenance, we manage obsolescence, cost reduction, design changes and regulatory updates for products in the field. This frees internal R&D teams to focus on the next generation of products.

Start with a gap assessment. Since February 2, 2026, the FDA’s Quality Management System Regulation has incorporated ISO 13485:2016 by reference into 21 CFR Part 820. Priority areas include risk management across processes, design controls, supplier controls and inspection readiness. LTTS helps teams assess and remediate their QMS, configure eQMS workflows and strengthen CAPA, change control and audit management, so compliance becomes an everyday habit rather than a last-minute scramble.

Connected devices need testing across hardware, software, connectivity, cybersecurity and usability. Typical scope includes software V&V aligned to IEC 62304, IEC 60601 electrical safety and EMC, wireless coexistence, interoperability with apps and cloud platforms, penetration testing and human factors validation. LTTS supports test strategy, automation, protocols and reports, with full traceability to requirements and risks, so the evidence is ready for submission when you need it.

LTTS applies AI where it has a measurable impact. In diagnostics, Digital Twin, Chest-rAi™ helps radiologists separate normal from abnormal chest X-rays, and our software-defined endoscopy, built with NVIDIA, enables real-time image enhancement and polyp detection. In quality and regulatory work, QAssure.ai makes compliance more predictable. In engineering, AI speeds up design, testing and sustenance. Clinical and regulatory experts stay in control of every decision.