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TÜV SÜD Product Service is a global leader in testing, inspection, and certification services, specifically serving as one of the world's largest Notified Bodies for medical devices and in vitro diagnostics. The company provides comprehensive market access solutions, including CE marking for the European Union under MDR and IVDR, MDSAP audits, and regulatory testing for a wide range of healthcare products. Its services cover the entire product lifecycle, from design and development to clinical evaluation and post-market surveillance. By ensuring compliance with international standards like ISO 13485, it enables manufacturers to bring safe and effective medical technologies to global markets. The organization also offers specialized services for digital health, cybersecurity in medical devices, and laboratory testing for biocompatibility and electrical safety.
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