10/13/2023 0 Comments Iso 13485 definitionISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices.Ĭertification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit. ISO 13485 PowerPoint Training Materials.ISO 13485 Online Training Course Listing.ISO 13485 Internal Auditor Training Courses.ISO 13485 Lead Auditor Training Courses.Simple Steps to ISO 13485 Certification Follow our proven and manageable step-by-step process for a successful ISO implementation project.
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