![]() ![]() Understand the requirements of the ISO 13485:2016 standard.Understanding the TPECS Course Structure page. This course covers Exemplar Global TPECS MD - Medical Device SystemsĬompetency Unit whose outcomes are certified by Exemplar Global.Īttendees successfully completing this course receive a Certificate ofĬompetency for this Exemplar Global Competency Unit. Students learn by participating in group exercises and in-depth ![]() Principles and includes auditing the requirements of the standard. ![]() AnĮxperienced instructor explains the clauses of ISO 13485:2016 inĭetail, providing a base for understanding the Medical Device Operations of organizations in the Medical Device industry. That teaches a general understanding of the concepts of the ISOġ3485:2016 standard and how the requirements impact the day-to-day BSI's “ISO 13485:2016 Requirements” competency-based ![]()
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