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Medical Devices

ISO 14971 - Risk Management

Desiree Tarranco

ISO 14971: Definition, Requirements, and Implementation

Medical DevicesRisk Management

Man pushing a trolley in a manufacturing facility

Farha Sayeed

Medical Device Supplier Management: Definition, Requirements, and Process

Medical DevicesSupplier

CE Marking and EU Illustration

Farha Sayeed

CE Marking for Medical Devices: Definition, Requirements, and How to Get It

Medical Devices

Illustration of an Integrated ISO 13485 QMS

Desiree Tarranco

ISO 13485: Definition, Requirements, and Certification

Medical DevicesQMSRegulations

EU IVDR Medical Device Classification

Desiree Tarranco

EU IVDR Medical Device Classification: Classes, Examples, and Rules

Medical Devices

ISO 13485 Audits Featured Illustration

Farha Sayeed

ISO 13485 Audits: Definition, Types, Process, and How to Prepare

AuditsMedical Devices

EU IVDR Illustration

Desiree Tarranco

EU IVDR: Definition, Requirements, and Compliance

Medical DevicesRegulations

Illustration of an Auditor Observing Documents with a magnifying glass

Farha Sayeed

Medical Device Audits: Definition, Types, Requirements, and Process

AuditsMedical Devices

Quality Management Illustration

Desiree Tarranco

Medical Device Quality Management System (QMS)

Medical DevicesQMS

Corrective and preventive action illustration

Desiree Tarranco

CAPA Management in the Medical Device Industry: Examples, Requirements, and Process

CAPAMedical Devices

Post-Market Surveillance Data Analysis

Desiree Tarranco

Medical Device Post-Market Surveillance (PMS)

Medical DevicesPost-Market Surveillance

DHF vs. DMR vs. DHR: Differences and Relations

Desiree Tarranco

DHF vs. DMR vs. DHR: Differences and Relations

Medical Devices

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