꯲ ꯆꯍꯤ ꯱꯴ꯒꯤ ꯄ꯭ꯔꯣꯐꯦꯁ꯭ꯅꯦꯜ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯗꯤꯚꯥꯏꯁ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯦꯂꯁ ꯑꯦꯛꯁꯄꯤꯔꯤꯑꯦꯟꯁ

2 ISO 13485:2016 ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯟ / ꯁꯤ.ꯏ.

1 ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯀꯣꯄꯤꯁꯤꯡ ꯄꯤꯕꯥ

꯲ ꯚꯤꯗꯤꯑꯣ ꯐꯦꯛꯇꯔꯤ ꯏꯟꯁꯄꯦꯛꯁꯅꯒꯤ ꯊꯧꯔꯥꯡ ꯇꯧꯕꯥ ꯌꯥꯏ

ꯁ꯭ꯄꯥꯏꯅꯦꯜ, ꯏꯟꯠꯔꯥꯃꯦꯗꯨꯂꯦꯔꯤ ꯅꯦꯂꯁꯤꯡ, ꯂꯣꯀꯤꯡ ꯄ꯭ꯂꯦꯠꯁꯤꯡ, ꯀꯟꯚꯦꯟꯁꯅꯦꯜ ꯄ꯭ꯂꯦꯠꯁꯤꯡ, ꯖꯣꯅꯁꯤꯡ, ꯁ꯭ꯄꯣꯔꯇꯁ ꯃꯦꯗꯤꯁꯤꯟ, ꯃꯄꯥꯅꯒꯤ ꯐꯤꯛꯁꯦꯁꯟ, ꯏꯂꯦꯛꯠꯔꯤꯛ ꯗ꯭ꯔꯤꯂꯁꯤꯡ, ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ

1 ꯀꯤ ꯄ꯭ꯔꯣꯁꯦꯁ ꯑꯣꯇꯣꯃꯦꯁꯅꯒꯤ ꯆꯥꯡ ≥95%

꯲ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯄ꯭ꯔꯗꯛꯁꯟ ꯀꯟꯠꯔꯣꯜ ꯄ꯭ꯔꯣꯁꯤꯖꯔꯁꯤꯡ ꯑꯀꯅꯕꯥ ꯊꯕꯛ ꯑꯣꯏꯅꯥ ꯄꯥꯡꯊꯣꯀꯄꯥ

1 ꯃꯄꯨꯡ ꯐꯥꯕꯥ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯔꯦꯀꯣꯔꯗ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ

2 ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯑꯣꯏꯕꯥ ꯄꯣꯠꯊꯣꯀꯁꯤꯡ: ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.꯱ ꯄꯤꯁ

꯲ ꯀꯁ꯭ꯇꯝ ꯄ꯭ꯔꯗꯛꯇꯁꯤꯡ: ꯀꯦꯁ ꯑꯃꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯀꯦꯁ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯈꯤꯕꯥ

1 ꯆꯥꯡ ꯅꯥꯏꯅꯥ ꯑꯣꯔꯗꯔ ꯇꯧꯕꯥ: ꯊꯕꯛ ꯅꯨꯃꯤꯠ ꯷ꯅꯤꯒꯤ ꯃꯅꯨꯡꯗꯥ ꯊꯥꯗꯣꯀꯎ

꯲ ꯈꯨꯗꯛꯀꯤ ꯑꯣꯏꯕꯥ ꯑꯣꯔꯗꯔꯁꯤꯡ: ꯅꯨꯃꯤꯠ ꯳-꯵ꯅꯤ (ꯁ꯭ꯇꯣꯛ ꯀꯅꯐꯔꯝ ꯇꯧꯕꯒꯤ ꯁꯕꯖꯦꯛꯇ)

1 ꯏꯟꯇꯔꯅꯦꯁꯅꯦꯜ ꯑꯦꯛꯁꯞꯔꯦꯁ (DHL/FEDEX/UPS): ꯅꯨꯃꯤꯠ 7-15ꯅꯤ

꯲ ꯑꯦꯌꯔ ꯐ꯭ꯔꯦꯠ: 0ꯅꯨꯃꯤꯠ ꯱ -꯲꯵ꯅꯤ

1 ꯄ꯭ꯔꯣꯐꯦꯁꯅꯦꯜ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ ꯇꯤꯃꯅꯥ ꯃꯄꯨꯡ ꯑꯣꯏꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯁꯄꯣꯔꯠ ꯄꯤꯔꯤ
2 ꯁꯥꯏꯟꯇꯤꯐꯤꯛ ꯁꯤꯄꯤꯡ ꯁꯣꯂꯨꯁꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯀꯁ꯭ꯇꯃꯁ ꯀ꯭ꯂꯤꯌꯔꯦꯟꯁ ꯑꯦꯁꯤꯁ꯭ꯇꯦꯟꯁ ꯄꯤꯔꯤ

ꯑꯦꯛꯁꯞꯔꯦꯁ/ꯑꯦꯌꯔ ꯐ꯭ꯔꯦꯠ: ꯇꯁꯦꯡꯕꯥ ꯑꯔꯨꯝꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯚꯣꯜꯌꯨꯃꯦꯠꯔꯤꯛ ꯑꯣꯏꯕꯥ ꯑꯔꯨꯝꯕꯥ ꯑꯗꯨꯅꯥ ꯆꯥꯔꯖ ꯇꯧꯕꯥ ꯑꯣꯔꯗꯔꯒꯤ

1 ꯁꯤꯄꯃꯦꯟꯇ ꯇꯧꯗ꯭ꯔꯤꯉꯩꯒꯤ ꯃꯃꯥꯡꯗꯥ ꯄꯣꯠꯊꯣꯛ ꯐꯣꯇꯣꯁꯤꯡ ꯄꯤꯕꯥ

2 ꯏꯟꯇꯔꯅꯦꯁꯅꯦꯜ ꯇ꯭ꯔꯦꯀꯤꯡ ꯅꯝꯕꯔ ꯄꯤꯕꯥ (ꯔꯤꯌꯦꯜ-ꯇꯥꯏꯝ ꯇ꯭ꯔꯦꯀꯤꯡ ꯑꯁꯤ 2019ꯗꯥ ꯐꯪꯒꯅꯤ꯫