TÜV SÜD is an international testing and certification organization that supports regulated industries, including medical devices and in vitro diagnostics. In healthcare, it helps manufacturers demonstrate safety, performance and quality system compliance needed for approvals and global market entry.

Medical device services

TÜV SÜD performs laboratory testing across electrical, mechanical, software and functional safety domains, alongside usability and risk-related evaluations. It also audits production and quality management systems and supports conformity assessment pathways.

Compliance role

By combining test houses, inspections and certification expertise, TÜV SÜD enables manufacturers to align product development with regulatory requirements. This reduces rework and helps streamline documentation and evidence packages for authorities and notified bodies.