Name: ISO 13485:2016(Government Charges extra if applicable)
SKU: 2831
Availability: InStock

ISO 13485:2016(Government Charges extra if applicable)

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Benefits of ISO 13485:2016 (Short)

Ensures regulatory compliance (FDA, CE, MDR).
Improves product quality and patient safety.
Enables global market access.
Builds customer trust.
Enhances operational efficiency.
Strengthens risk management.
Drives continuous improvement.
Provides legal protection.

( Expected TAT Filing 48 Working Hour)

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Description

ISO 13485:2016 – Required Documents (Short)

Company registration & address proof
PAN & Aadhar of owners/directors
Quality Manual & Policy
Risk management file
Product specifications & technical files
SOPs & work instructions
Calibration & training records
Internal audit & CAPA reports

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