ISO 13485:2016 Quality Management System for Medical Devices

Certification & Training

ISO 13485 is the international standard that sets out the requirements for Quality Management System standard specifically for the medical devices industry. Considered as one of the most highly regulated sector in the world, the medical devices industry must demonstrate compliance with regulatory and product requirements to ensure safety and performance of medical devices produced. 

To support you in strengthening your quality management systems and processes for medical devices, TÜV SÜD offers a wide range of ISO 13485 certifications, instructor-led and live virtual training course.

YOUR BENEFITS AT A GLANCE

  • To gain access to markets with the most rigorous standards for medical devices and medical quality control
  • Gain the trust of stakeholders (regulators, primary producers, food manufacturers and packers, retailers and consumers)

AUDITING & SYSTEM CERTIFICATION

ISO 13485:2016 Management System Certification

ISO 13485 addresses the development, implementation, and maintenance of a quality management system intended for use by medical device manufacturers, suppliers, distributors, and other services that correspond to medical services. TÜV SÜD, as a certification body has received accreditation by applying ISO 17021 to be carried out compliance audits according to ISO 13485 standards. The audit team consists of experts with the skills and expertise needed to accurately assess the compliance of your management system. We will conduct in the local language, which will ease you to understand any requirement and change notices.

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ISO 13485 Internal Auditor Live Virtual Training

This two-day ISO 13485 internal auditor training will allow learners to understand the significant changes that affect registrants within the scheme, how the changes may impact them, and how to audit against the revised ISO 13485:2016 standard.

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ISO 13485 QMS for Medical Devices

Efficient medical device quality management and testing

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