DPS
Drejtoria e Përgjithshme e Standardizimit
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E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
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Standards for medical devices

Standards for medical devices define:

  • SSH EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
  • SSH EN ISO 14971:2019 Medical devices - Application of risk management to medical devices