It also incorporates the Technical Corrigendum ISO /Cor.1:2009. This third edition of ISO 13485 cancels and replaces the second edition (ISO ) and ISO/TR, which have been technically revised. Identify gaps in your current quality management system by performing regular audits using digital internal control checklists.Äownload free EU MDR and ISO 13485 PDF compliance materials: Checklist of mandatory documentation, Description of requirements, Implementation diagram, etc.
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