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QMS Lead Auditor Training

Medical device auditing requires a high degree of technical/process knowledge and a thorough understanding of the international medical device regulations. The auditor’s critical roles include planning, conducting, reporting and following up on a quality management system (QMS) audit in accordance with ISO 13485:2016, the Medical Device Single Audit Program (MDSAP) and ISO 19011 scheme requirements.

This five-day course provides the skilles and knowledge that have taken many experienced auditors decades to develop. During the course, you will plan and prepare audits based upon case studies that simulate both supplier and third-party audits utilizing the MDSAP audit requirements.

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We are looking forward to your participation!



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