Kelmac Group offers ISO 13485:2016 Training Courses in the USA, including Fundamental, Internal Auditor, and Lead Auditor programs. These accredited courses are designed to equip professionals with essential knowledge of medical device quality management systems, from basic principles to advanced auditing skills. Flexible virtual in-house training options are available, ensuring your team achieves compliance and drives business success. Enroll now to enhance your expertise!

COURSE OVERVIEW

Our Fundamental Courses comprehensively introduce Learners to Quality Management Systems and provide them with a highly insightful introduction to the purpose, intent, and requirements of ISO 13485:2016, plus the business case for adopting ISO 13485:2016.

The focus of the Internal Auditor Courses is on assisting and verifying the competencies & capabilities of the Learner to be able to effectively audit a process, activity, or department/function of a QMS based on ISO 13485:2016 requirements with specific emphasis on 1st Party auditing [Internal audits].

The Lead Auditor Courses are based on assisting and verifying the competencies/capabilities of the Learner to be able to effectively audit a complete QMS [MD] based on ISO 13485:2016 requirements and Medical Device Single Audit Program (MDSAP) requirements with a specific emphasis on 2nd Party auditing [Customer/Supplier audits] and 3rd Party auditing. Others train Followers. We train Leaders.™

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