Gain insight into the regulatory, technological and market access challenges shaping the future of surgical robotics.
Download NowTechnological trends in healthcare are reshaping surgical robotics
Robots in healthcare are evolving from mechanically assisted systems into complex, software- and AI-driven platforms. Advances in imaging, data processing, connectivity and decision-support capabilities are expanding what surgical robotics can achieve, while increasing system complexity and expectations around validation, transparency and real-world performance.
As a result, regulatory requirements are becoming more stringent. Surgical robotic systems must comply with the EU Medical Device Regulation (MDR). As AI becomes a core functional component, they will also fall under the scope of the upcoming EU Artificial Intelligence Act. Inconsistent global regulatory interpretations and the lack of standardised real-world performance benchmarks further complicate international expansion.
This white paper explores where innovation and regulation collide and what manufacturers need to consider to achieve sustainable global market access.
What you'll learn from this white paper
- Key advantages of robotics in healthcare within surgical applications
- Technological trends in healthcare influencing surgical robotic systems
- Market and regulatory factors affecting international expansion
- The impact of MDR and emerging AI-related requirements across the product lifecycle
- Why independent validation and evidence-based assessment are becoming critical for compliance
Maria Rosaria Palminteri
Senior Product Specialist for Surgical Robotics, TÜV SÜD
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