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Risk Management (ISO 14971) - SERKINDO
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Risk Management (ISO 14971)

ISO

Risk Management (ISO 14971)

by Serkindo 0 Comment

Kenapa ISO 13485 Penting?

Alat kesehatan menyangkut keselamatan manusia. Gagal mutu = risiko jiwa.
ISO 13485 memastikan bahwa:

✅ Produk aman, efektif, dan repeatable
✅ Proses terdokumentasi dan terkendali
✅ Risiko produk cacat ditekan sejak awal
✅ Memenuhi persyaratan legal (FDA, CE, ISO audit)
✅ Kepercayaan dari rumah sakit, klinik, dan pasien meningkat

 

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Kontak Kami :

  1. Sertifikasi Indonesia

Alamat : Jl. Pembinaan No.36, Lengkong Gudang Tim., Kec. Serpong, Kota Tangerang Selatan, Banten 15310

https://maps.app.goo.gl/oLkZnxuDKAUkM5Ko6

 

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