Auditing & System Certification | Training & Personal Certification
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. ISO 13485:2016 Medical Device Management Systems (MDMS) is the international standard that sets out the requirements for Quality Management System standard specifically for the medical devices industry.
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 courses.
This ISO 13485 awareness training will highlight the significant changes that affect registrants within the scheme, to help organisations understand some of the changes and how the changes may impact them.
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.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers.
TÜV SÜD Product Service is the largest EU Notified Body in the world, and our technical professionals have first-hand knowledge and in-depth expertise with all types of medical devices. In addition, we are a leading global management certification body for quality management systems, including management systems applicable in the manufacture of medical devices. With these experience, we can address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485 certification.
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Bosnia and Herzegovina