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Regulatory Compliance - SERKINDO
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Regulatory Compliance

Regulatory Compliance

Untuk Siapa ISO 13485?

ISO 13485 berlaku bagi organisasi yang terlibat dalam siklus hidup perangkat medis, antara lain:

  1. 🏭 Produsen alat kesehatan: dari syringe hingga ventilator
  2. 📦 Distributor & Importir: wajib menjamin mutu produk sampai ke pengguna akhir
  3. 🔬 Penyedia jasa: sterilisasi, pengemasan, kalibrasi
  4. 🧪 Peneliti & pengembang alat kesehatan
  5. 🧩 Subkontraktor & pemasok komponen elektronik, plastik, sensor, dll

 

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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

 

Phone : (021) 22352213

Whatapps : 0811 10555 509

Email : cs@serkindo.com

www.serkindo.com

Serkindo

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