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Medical Device Quality Management System (QMS) - SERKINDO
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Medical Device Quality Management System (QMS)

ISO

Medical Device Quality Management System (QMS)

by Serkindo 0 Comment

Apa Itu ISO 13485?

📌 ISO 13485 adalah standar internasional untuk sistem manajemen mutu khusus industri perangkat medis.
Fokus utama: memastikan produk alat kesehatan yang aman, efektif, dan sesuai regulasi.

Standar ini mencakup:

  • Desain & pengembangan
  • Produksi
  • Penyimpanan & distribusi
  • Instalasi & servis
  • Dokumentasi teknis & pelacakan produk

 

 

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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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Whatapps : 0811 10555 509

Email : cs@serkindo.com

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