TÜV SÜD gets NABCB accreditation for certifying medical devices organization

The accreditation will enable TÜV SÜD to grant certifications for ISO 13485, ICMED 9000 and ICMED 13485


German safety and quality expert, TÜV SÜD has recently received accreditation from National Accreditation Board for Certifying Bodies (NABCB) to grant certifications for ISO 13485, ICMED 9000 and ICMED 13485.

TÜV SÜD is the first and only independent Certification body till date in India to be accredited by NABCB to issue these certifications.

ISO 13485 specifies requirements for a quality management system that can benefit an organization right from design to practical usage of medical devices and related services. ICMED 9000 certification comprises of ISO 9001 plus additional requirements, whereas, ICMED 13485 includes ISO 13485 plus additional requirements. 

Commenting on the accreditation, Suresh Kumar, Vice President, Product Services TÜV SÜD South Asia said, "It is an honour for us to be the first certification body in India accredited by the NABCB to issue ISO 13485 and ICMED certifications. Global quality regulations for medical devices are among the most stringent as they safeguard patient interests."

He also added, "The ICMED Standard that TÜV SÜD offers is poised to build credibility of the manufacturers, secure user confidence that will subsequently uphold brand reputation. With our MDSAP services, we aim to provide manufacturers credibility, motivate them to increase their export footprint, empower them to gain easy access to exports and align with the government's ‘Make in India' program."


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