Under the guiding theme “NextGen MedTech – From idea to market access,” TÜV SÜD will present new approaches for faster, more efficient, and future-proof development of medical devices at COMPAMED 2025 in Düsseldorf from November 17 to 20. In times of increasing regulatory requirements, growing cost pressure, and demanding time-to-market targets, TÜV SÜD supports manufacturers in integrating clinical, regulatory, and technical requirements from the very beginning and thereby accelerating development processes in a targeted manner. Hall 8a / Booth J13.
The core idea of NextGen MedTech: rather than considering regulatory requirements and clinical evidence only in later development phases, all relevant requirements are integrated early and holistically. This creates an end-to-end development process that increases transparency, reduces iterations, and strengthens manufacturers’ innovative capacity. Companies benefit from TÜV SÜD’s global network of experts, which combines regulatory, clinical, and technical expertise.
The NextGen approach includes:
- Early integration of regulatory and risk management to ensure planning reliability and compliance.
- Clinical requirements and evidence concepts from the outset to prepare studies and documentation efficiently.
- Parallel technical validation, usability engineering, and verification to shorten development cycles.
- Iterative quality assurance with agile feedback loops.
- Digital tools and structured dialogue with TÜV SÜD experts to establish clarity at an early stage, avoid development errors, and accelerate market access.
“NextGen MedTech means understanding product development as an integrated process that combines innovation, quality, and safety,” explains Ralf Gansel, Head of Sales DACH, Medical Devices at TÜV SÜD. “When technical, clinical, and regulatory aspects work together from day one, market access becomes faster and products become more robust at the same time.”
At COMPAMED 2025, which runs concurrently with MEDICA in Düsseldorf, TÜV SÜD will be presenting this approach. Visitors can experience practical scenarios – from the initial idea and risk analysis through to market launch and lifecycle support. The exhibition stand offers space for professional discussions and individual exchange on best-practice examples from ongoing projects. In addition, the trade fair team will provide information on new services in usability engineering, post-market surveillance, and clinical evaluation. TÜV SÜD will also present offerings in testing that complement classical inspection and certification, including targeted test campaigns as well as simulation and verification services to validate products at an early stage and prepare them for market readiness.
“NextGen MedTech” addresses central challenges facing the industry: regulatory requirements are becoming more complex, time to market is shortening, and budgets are tightening, while expectations regarding quality, safety, and innovation continue to rise. A key building block in this context is cybersecurity: TÜV SÜD offers comprehensive testing and assessment services – from threat modeling and vulnerability analysis to penetration testing and comprehensive cybersecurity concept assessments – either directly at customer sites or in testing laboratories. This allows manufacturers to demonstrate at an early stage that connected medical devices are resilient to attacks and that regulatory requirements under MDR/IVDR as well as relevant standards such as IEC/TR 60601-4-5 or UL 2900-2-1 are met.
In addition, TÜV SÜD focuses on future topics such as robotics in surgical environments. Robotic systems, assistive devices, and automated operating-room controls open up new opportunities, but also entail challenges related to complexity and safety. With its expertise in functional safety and cybersecurity, TÜV SÜD helps manufacturers design robotic applications in a way that is verifiable, safe, and compliant with regulatory requirements.
In this field of tension, TÜV SÜD provides a methodological framework that creates transparency, reduces development risks, and systematically leverages efficiency potential – from start-ups to global MedTech companies. In this way, TÜV SÜD supports organizations of all sizes in accelerating their innovation cycles and bringing safe, high-performance medical devices to market faster.
