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QMS Self-Assessments

IMSI offers two self-assessments: ISO 13485 and MDR (Medical Device Regulation)

These assessments are intended for gap analysis, preparation for internal/external audits and more. 

ISO 13485:2016 Self-Assessment

ISO 13485:2016 Self-Assessment

Our self-assessment provides you and your team with an opportunity to identify areas of strength within your quality management system and opportunities for improvement.  The assessment covers ISO 13485:2016. Major sections include questions to assess your organizations understanding of the standard, questions to evaluate the robustness of your quality management system and provide a detailed PDF with your results.

Free

MDR Self Assessment

This is a self-assessment for MDR

Free