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sertifikasi ISO 13485 Indonesia - SERKINDO
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sertifikasi ISO 13485 Indonesia

ISO

sertifikasi ISO 13485 Indonesia

by Serkindo 0 Comment

Siapa Saja yang Wajib Menerapkan ISO 13485?

Bukan hanya produsen alat kesehatan yang wajib menerapkan ISO 13485, tetapi juga distributor, importir, dan penyedia layanan terkait seperti kalibrasi, instalasi, atau perawatan perangkat medis. Standar ini sangat penting bagi perusahaan yang ingin memperluas pasar, terutama untuk ekspor ke Eropa dan negara-negara yang mewajibkan sertifikasi ini sebagai bukti sistem mutu yang memadai. Kepatuhan terhadap ISO 13485 menjadi syarat mutlak dalam audit dan inspeksi regulator kesehatan di berbagai negara.

 

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  1. Sertifikasi Indonesia

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