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Showing posts from November, 2021

MDQMS 13485:2016(MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM)

            MDQMS 13485:2016(MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM) Course  Overview : v     The   purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system. EligibilityCriteria:- Some specific Medical Device knowledge and Min. 4 years working experience is required. This is anintensivecourse.   Beforestartingthiscourse,studentsareexpectedtohavethefollowingpriorknowledge:   ISO MDQMS 13485:2016  Course Content   LeadAuditorTraining Course ISO 13485:2016 – Medical Device- QualityManagementSystem A  Third-Party  Assessor or Lead  Assessor of   ISO 13485:2016 Responsible  for undertaking audits  of  suppliers/subcontractors as  per ISO13485:2016 Responsible for implementing internal audits and audit programs as per ISO 13485:2016 Responsible for implementing the I