ISO 13485:2016 - Quality Management Systems for Medical Devices | couponradarr

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ISO 13485:2016 - Quality Management Systems for Medical Devices

1.5-3hrs

beginner level

This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal certifications and look closely at standard terminologies related to stakeholders, product, QMS, Risk and Sterilization, and more!

ISO 13485:2016 - Quality Management Systems for Medical Devices

In this free online course learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.

Introduction to ISO 13485:2016 (Medical Devices' QMS)

This module explains the existing relevant standards and regulation for medical devices' industry and enlightens the revision of ISO 13485. It also presents some important terminologies with related definitions as defined by ISO 13485; which are arranged in separate groups. It also covers the comparison of ISO 13485 to FDA 21 CFR Part 820. All mandatory documents required by different clauses of the ISO 13485:2016 standard are also enumerated in this module along with its given clause reference.