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manfaat ISO 13485 bagi UMKM medis - SERKINDO
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manfaat ISO 13485 bagi UMKM medis

ISO

manfaat ISO 13485 bagi UMKM medis

by Serkindo 0 Comment

ISO 13485 dalam Konteks Global dan Regulasi Ekspor Alkes

ISO 13485 diakui secara internasional sebagai bukti kepatuhan terhadap peraturan keamanan perangkat medis. Banyak negara seperti Jerman, Kanada, dan Jepang menjadikan sertifikasi ini sebagai persyaratan dasar dalam memasukkan produk ke pasar mereka. Di Uni Eropa, ISO 13485 menjadi bagian penting untuk memperoleh CE Marking, sedangkan di Amerika Serikat, kepatuhan terhadap FDA Quality System Regulation (QSR) dapat lebih mudah dicapai jika perusahaan telah menerapkan ISO 13485. Dengan kata lain, sertifikasi ini adalah tiket masuk ke pasar global yang penuh regulasi ketat.

 

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