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ꯑꯗꯣꯝ ꯃꯐꯝ ꯑꯁꯤꯗꯥ ꯂꯩꯔꯤ: ꯌꯨꯝ » ꯑꯦꯛꯁꯁꯤ ꯑꯣꯔꯊꯣ ꯏꯅꯁꯥꯏꯠꯁ꯫ » ꯏꯟꯗꯁ꯭ꯠꯔꯤꯒꯤ ꯃꯤꯠꯌꯦꯡꯁꯤꯡ꯫ » ꯲꯰꯲꯶ꯇꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ ꯀꯔꯝꯅꯥ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯒꯅꯤ: ꯷ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ꯫

꯲꯰꯲꯶ꯇꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ ꯀꯔꯝꯅꯥ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯒꯅꯤ: ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯷꯫

ꯌꯦꯡꯈꯤꯕꯥ: 22     ꯑꯏꯕꯥ: ꯁꯥꯏꯠ ꯑꯦꯗꯤꯇꯔ ꯐꯣꯉꯕꯥ ꯃꯇꯝ: ꯲꯰꯲꯶-꯰꯴-꯱꯳ ꯍꯧꯔꯀꯐꯝ: ꯃꯐꯝ

꯲꯰꯲꯶ꯀꯤ ꯀ꯭ꯔꯦꯇꯥꯒꯤ ꯒꯥꯏꯗꯂꯥꯏꯟ · ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ꯫

ꯑꯃꯥ ꯈꯅꯕꯁꯤ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯑꯃꯁꯨꯡ ꯀꯟꯇꯤꯟꯌꯨꯏꯇꯤꯒꯤ ꯋꯥꯔꯦꯞ ꯑꯃꯅꯤ-ꯃꯃꯜ ꯆꯥꯡꯗꯝꯅꯕꯈꯛꯇꯗꯥ ꯅꯠꯇꯦ꯫ ꯲꯰꯲꯶ꯇꯥ ꯀ꯭ꯔꯦꯇꯥꯁꯤꯡꯅꯥ ꯍꯧꯖꯤꯛ ꯂꯩꯔꯤꯕꯥ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯔꯦꯗꯤꯑꯣ, ꯄ꯭ꯔꯗꯛꯇ-ꯂꯦꯕꯦꯜ ꯗꯣꯀꯨꯃꯦꯟꯇꯦꯁꯟ, ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ, ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ, ꯗꯦꯂꯤꯕꯔꯤ ꯏꯕꯤꯗꯦꯟꯁ, ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡ ꯁꯄꯣꯔꯠ, ꯑꯃꯁꯨꯡ ꯄꯣꯁ꯭ꯠ-ꯃꯥꯔꯀꯦꯠ ꯔꯦꯁ꯭ꯄꯣꯟꯁ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯒꯗꯕꯅꯤ꯫ ꯒꯥꯏꯗꯂꯥꯏꯟ ꯑꯁꯤꯅꯥ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯑꯗꯨ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯷ꯀꯤ, ꯄꯣꯏꯟꯇ ꯱꯰꯰ꯒꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯁ꯭ꯀꯣꯔꯀꯥꯔꯗ ꯑꯃꯗꯥ ꯑꯣꯟꯊꯣꯀꯏ꯫

ꯑꯍꯥꯅꯕꯗꯥ ꯒꯦꯠ ꯀꯝꯞꯂꯥꯏꯑꯦꯟꯁ ꯂꯦꯡ- ꯑꯣꯠꯄꯒꯤ ꯃꯃꯜ ꯅꯦꯝꯕꯥ ꯂꯤꯒꯦꯜ, ꯔꯦꯒꯨꯂꯦꯇꯔꯤ, ꯀ꯭ꯕꯥꯂꯤꯇꯤ-ꯁꯤꯁ꯭ꯇꯦꯝ, ꯅꯠꯠꯔꯒꯥ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤꯒꯤ ꯄ꯭ꯔꯃꯥꯅꯁꯤꯡ ꯑꯗꯨ ꯀꯝꯄꯦꯟꯁꯦꯁꯟ ꯇꯧꯔꯣꯏꯗꯕꯅꯤ꯫
ꯁ꯭ꯀꯣꯔ ꯑꯣꯕꯖꯦꯛꯇꯤꯚ ꯏꯚꯤꯗꯦꯟꯁ ꯋꯥꯍꯩꯅꯥ ꯀ꯭ꯂꯦꯝ ꯑꯃꯅꯥ ꯍꯧꯖꯤꯛ ꯂꯩꯔꯤꯕꯥ, ꯄ꯭ꯔꯗꯛꯇ-ꯂꯤꯉ꯭ꯛ ꯇꯧꯕꯥ ꯑꯃꯁꯨꯡ ꯃꯁꯥ ꯃꯊꯟꯇꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯌꯥꯕꯥ ꯔꯦꯀꯣꯔꯗ ꯑꯃꯗꯒꯤ ꯍꯦꯟꯅꯥ ꯁꯦꯜ ꯆꯪꯏ꯫
ꯑꯦꯞꯔꯨꯚ ꯇꯧꯔꯕꯥ ꯃꯇꯨꯡꯗꯥ ꯃꯣꯅꯤꯇꯔ ꯇꯧꯕꯥ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯅꯅꯥ ꯃꯔꯤ ꯑꯗꯨ ꯍꯧꯗꯣꯀꯄꯥ; ꯑꯁꯣꯏ-ꯑꯉꯥꯝ ꯌꯥꯑꯣꯗꯕꯥ, ꯑꯍꯣꯡꯕꯥ, ꯗꯦꯂꯤꯕꯔꯤ, ꯀꯃꯞꯂꯦꯟꯇ, ꯑꯃꯁꯨꯡ ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ.ꯅꯥ ꯃꯈꯥ ꯇꯥꯅꯥ ꯑꯌꯥꯕꯥ ꯄꯤꯕꯒꯤ ꯋꯥꯔꯦꯞ ꯂꯧꯏ꯫
꯲꯰꯲꯶ꯀꯤ ꯑꯣꯏꯅꯥ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯷ ꯌꯥꯑꯣꯕꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯏꯚꯥꯂꯨꯑꯦꯁꯟ ꯁ꯭ꯀꯣꯔꯀꯥꯔꯗ꯫
ꯀꯥꯟꯅꯕꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯁ꯭ꯀꯣꯔꯀꯥꯔꯗ ꯑꯃꯅꯥ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯀꯝꯞꯂꯥꯏꯑꯦꯟꯁ ꯒꯦꯠꯁꯤꯡ ꯑꯁꯤ ꯀꯝꯃꯔꯁꯤꯑꯦꯜ ꯑꯃꯁꯨꯡ ꯑꯣꯄꯔꯦꯁꯅꯦꯜ ꯗꯤꯐꯦꯟꯁꯔꯤꯁꯤꯡꯗꯒꯤ ꯇꯣꯉꯥꯟꯅꯥ ꯊꯝꯂꯤ꯫

꯲꯰꯲꯶ꯇꯥ ꯑꯗꯣꯝꯅꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ ꯀꯔꯝꯅꯥ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯒꯗꯒꯦ?

ꯂꯦꯌꯔ ꯃꯔꯤ ꯂꯩꯕꯥ ꯔꯤꯁ꯭ꯀꯇꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯑꯃꯥ ꯁꯤꯖꯤꯟꯅꯧ: ꯄ꯭ꯔꯤ-ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ, ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ, ꯁꯦꯝꯄꯜ ꯅꯠꯠꯔꯒꯥ ꯄꯥꯏꯂꯣꯠ ꯚꯦꯂꯤꯗꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯍꯧꯖꯤꯛ ꯆꯠꯊꯔꯤꯕꯥ ꯄꯔꯐꯣꯃꯦꯟꯁ ꯃꯣꯅꯤꯇꯔ ꯇꯧꯕꯥ꯫ ꯑꯦꯔꯤꯌꯥ ꯷ ꯁ꯭ꯀꯣꯔ ꯇꯧ, ꯑꯗꯨꯕꯨ ꯂꯤꯒꯦꯜ ꯑꯥꯏꯗꯦꯟꯇꯤꯇꯤ, ꯄ꯭ꯔꯗꯛꯇ ꯑꯣꯊꯣꯔꯥꯏꯖꯦꯁꯟ, ꯀ꯭ꯕꯥꯂꯤꯇꯤ-ꯁꯤꯁ꯭ꯇꯦꯝ ꯀꯚꯔꯦꯖ, ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ, ꯑꯃꯁꯨꯡ ꯃꯔꯨꯑꯣꯏꯕꯥ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯅꯁꯤꯡ ꯑꯁꯤ ꯄꯥꯁ/ꯐꯦꯜ ꯒꯦꯠ ꯑꯣꯏꯅꯥ ꯂꯧ꯫

ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯐꯕꯥ ꯑꯄꯤꯀꯄꯥ ꯄꯥꯎꯈꯨꯝ: ꯑꯀꯛꯅꯕꯥ ꯄꯣꯠꯊꯣꯛ, ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯁꯥꯏꯠ, ꯗꯦꯁ꯭ꯇꯤꯅꯦꯁꯟ ꯃꯥꯔꯀꯦꯠ, ꯑꯃꯁꯨꯡ ꯁꯞꯂꯥꯏ-ꯆꯦꯅꯒꯤ ꯊꯧꯗꯥꯡꯒꯤꯗꯃꯛꯇꯥ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯀꯅꯕꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯔꯕꯥ ꯄ꯭ꯔꯃꯥꯟ ꯄꯤꯕꯥ ꯉꯝꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨ ꯈꯜꯂꯨ-ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯁꯥꯡꯕꯥ ꯀꯦꯇꯥꯂꯣꯒ ꯅꯠꯠꯔꯒꯥ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯅꯦꯝꯕꯥ ꯑꯍꯥꯅꯕꯥ ꯀꯣꯇꯦꯁꯟ ꯂꯩꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨ ꯅꯠꯇꯦ꯫

꯲꯰꯲꯶ꯇꯥ ꯃꯦꯗꯤꯀꯦꯜ ꯗꯤꯚꯥꯏꯁ ꯁꯞꯂꯥꯏꯌꯔ ꯏꯚꯥꯂꯨꯑꯦꯁꯅꯗꯥ ꯀꯔꯤ ꯑꯍꯣꯡꯕꯥ ꯂꯥꯀꯈꯤꯕꯒꯦ?

ꯇꯥꯏꯇꯂꯗꯥ ꯌꯥꯎꯔꯤꯕꯥ ꯆꯍꯤ ꯑꯗꯨ ꯇꯁꯦꯡꯕꯥ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯍꯣꯡꯂꯀꯄꯁꯤꯡꯒꯥ ꯃꯥꯟꯅꯒꯗꯕꯅꯤ꯫ ꯗꯤꯕꯦꯂꯄꯃꯦꯟꯇ ꯑꯅꯤꯅꯥ ꯲꯰꯲꯶ꯇꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔꯁꯤꯡ, ꯏꯝꯄꯣꯔꯇꯔꯁꯤꯡ, ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯕ꯭ꯔꯥꯟꯗ ꯑꯣꯅꯔꯁꯤꯡꯗꯥ ꯃꯆꯥꯛ ꯃꯊꯨꯃꯒꯤ ꯑꯣꯏꯅꯥ ꯁꯣꯀꯍꯜꯂꯤ꯫

ꯐꯦꯕ꯭ꯔꯨꯋꯥꯔꯤ ꯲, ꯲꯰꯲꯶ꯇꯒꯤ ꯆꯠꯅꯕꯥ ꯍꯧꯔꯒꯅꯤ꯫

ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯝ ꯔꯦꯒꯨꯂꯦꯁꯟ꯫

ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯝ ꯔꯦꯒꯨꯂꯦꯁꯟ ꯑꯁꯤ ꯏꯐꯦꯛꯇꯤꯕ ꯑꯣꯏꯈꯤ ꯑꯃꯁꯨꯡ ꯌꯨ.ꯑꯦꯁ.ꯀꯤ ꯑꯀꯛꯅꯕꯥ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯔꯤꯐꯔꯦꯟꯁꯀꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ. ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯅꯥ ꯑꯄꯗꯦꯠ ꯇꯧꯔꯕꯥ ꯃꯦꯗꯤꯀꯦꯜ-ꯗꯤꯚꯥꯏꯁ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯄ꯭ꯔꯣꯁꯦꯁ ꯑꯃꯁꯨ ꯁꯤꯖꯤꯟꯅꯕꯥ ꯍꯧꯈꯤ꯫ ꯃꯔꯝ ꯑꯗꯨꯅꯥ ꯌꯨ.ꯑꯦꯁ.-ꯃꯥꯔꯀꯦꯠ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ ꯑꯁꯤꯅꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.ꯒꯤ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯑꯃꯥ ꯂꯩꯕꯈꯛꯇꯗꯥ ꯅꯠꯇꯅꯥ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.

꯲꯰꯲꯶ꯀꯤ ꯃꯦ ꯲꯸ꯗꯒꯤ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯑꯣꯏꯒꯅꯤ꯫

ꯑꯍꯥꯅꯕꯥ ꯏꯎ.ꯗꯤ.ꯑꯦ.ꯑꯦꯝ.ꯏ.ꯗꯤ.ꯒꯤ ꯃꯣꯗ꯭ꯌꯨꯜ ꯃꯔꯤ꯫

ꯑꯍꯥꯅꯕꯥ ꯏ.ꯌꯨ.ꯗꯤ.ꯑꯦ.ꯑꯦꯝ.ꯏ.ꯗꯤ.ꯒꯤ ꯃꯣꯗ꯭ꯌꯨꯜ ꯃꯔꯤ ꯑꯁꯤ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯑꯣꯏꯈꯤ: ꯑꯦꯛꯇꯔ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ, ꯌꯨ.ꯗꯤ.ꯑꯥꯏ./ꯗꯤꯚꯥꯏꯁ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ, ꯅꯣꯇꯤꯐꯥꯏꯗ ꯕꯣꯗꯤꯁꯤꯡ & ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯃꯥꯔꯀꯦꯠ ꯁꯔꯚꯤꯂꯦꯟꯁ꯫ ꯏꯌꯨꯗꯥ ꯃꯤꯠꯌꯦꯡ ꯊꯝꯕꯥ ꯔꯤꯚꯤꯌꯨꯁꯤꯡꯗꯥ ꯑꯦꯁ.ꯑꯥꯔ.ꯑꯦꯟ., ꯗꯤꯚꯥꯏꯁ ꯑꯃꯁꯨꯡ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯗꯦꯇꯥ, ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯑꯦꯂꯥꯏꯟꯃꯦꯟꯇ, ꯑꯃꯁꯨꯡ ꯏꯀꯣꯅꯣꯃꯤꯛ ꯑꯣꯄꯔꯦꯇꯔ ꯈꯨꯗꯤꯡꯃꯛꯀꯤ ꯊꯧꯗꯥꯡꯁꯤꯡ ꯌꯥꯑꯣꯒꯗꯕꯅꯤ꯫

ꯃꯔꯨꯑꯣꯏꯕꯥ ꯈꯦꯠꯅꯕꯥ: ISO 13485 ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯅꯅꯥ ꯀ꯭ꯕꯥꯂꯤꯇꯤ-ꯁꯤꯁ꯭ꯇꯦꯝ ꯏꯚꯥꯜꯌꯨꯑꯦꯁꯟ ꯁꯄꯣꯔꯠ ꯇꯧꯏ, ꯑꯗꯨꯕꯨ ꯃꯁꯤꯅꯥ ꯀꯦꯇꯥꯂꯣꯒ ꯑꯃꯗꯥ ꯂꯩꯕꯥ ꯄꯣꯠꯊꯣꯛ ꯈꯨꯗꯤꯡꯃꯛ ꯑꯣꯊꯣꯔꯥꯏꯖ ꯇꯧꯗꯦ꯫ ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯏꯁ꯭ꯇꯥꯕ꯭ꯂꯤꯁꯃꯦꯟꯇ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ ꯍꯥꯌꯕꯁꯤ ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯑꯌꯥꯕꯥ, ꯀ꯭ꯂꯤꯌꯔꯦꯟꯁ ꯅꯠꯠꯔꯒꯥ ꯑꯣꯊꯣꯔꯥꯏꯖꯦꯁꯟ ꯍꯥꯌꯕꯁꯤꯅꯤ꯫ ꯁꯤ.ꯏ.

ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯏꯚꯥꯜꯌꯨꯑꯦꯁꯟ ꯐ꯭ꯔꯦꯃꯋꯥꯔꯛ ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯁꯤꯖꯤꯟꯅꯒꯗꯒꯦ꯫

ꯁ꯭ꯇꯦꯖ 1: ꯄ꯭ꯔꯤ-ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ ꯂꯤꯒꯦꯜ ꯑꯥꯏꯗꯦꯟꯇꯤꯇꯤ, ꯄ꯭ꯔꯗꯛꯇ ꯁ꯭ꯀꯣꯞ, ꯇꯥꯔꯒꯦꯠ ꯃꯥꯔꯀꯦꯠꯁꯤꯡ, QMS ꯀꯚꯔꯦꯖ, ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯁ꯭ꯇꯦꯇꯁ, ꯑꯃꯁꯨꯡ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯁꯤꯡ ꯀꯅꯐꯥꯔꯝ ꯇꯧꯕꯥ꯫
ꯁ꯭ꯇꯦꯖ 2: ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ ꯁꯔꯇꯤꯐꯤꯀꯦꯇꯁꯤꯡ ꯚꯦꯂꯤꯗꯦꯠ ꯇꯧꯕꯥ, ꯁꯦꯝꯄꯜ ꯂꯣꯠ ꯑꯃꯥ ꯇ꯭ꯔꯦꯁ ꯇꯧꯕꯥ, ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ, ꯐꯦꯛꯇꯔꯤ ꯑꯗꯨ ꯑꯦꯁꯦꯁ ꯇꯧꯕꯥ, ꯑꯃꯁꯨꯡ ꯔꯤꯞꯔꯖꯦꯟꯇꯦꯇꯤꯚ ꯁꯦꯝꯄꯂꯁꯤꯡ ꯇꯦꯁ꯭ꯠ ꯇꯧꯕꯥ꯫
ꯁ꯭ꯇꯦꯖ 3: ꯑꯦꯞꯔꯨꯚꯦꯜ & ꯃꯣꯅꯤꯇꯔ ꯇꯧꯕꯥ ꯑꯣꯄꯟ ꯑꯦꯛꯁꯅꯁꯤꯡ ꯊꯤꯡꯖꯤꯅꯕꯥ, ꯀ꯭ꯕꯥꯂꯤꯇꯤ/ꯆꯦꯟꯖ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇꯁꯤꯡ ꯁꯥꯏꯟ ꯇꯧꯕꯥ, ꯑꯍꯥꯅꯕꯥ ꯂꯣꯠ ꯑꯗꯨ ꯑꯦꯞꯔꯨꯚ ꯇꯧꯕꯥ, ꯑꯃꯁꯨꯡ ꯀ꯭ꯕꯥꯂꯤꯇꯤ, ꯗꯦꯂꯤꯚꯔꯤ, ꯀꯃꯞꯂꯦꯟꯇꯁꯤꯡ, ꯑꯃꯁꯨꯡ CAPA ꯌꯦꯡꯁꯤꯅꯕꯥ꯫

ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯒꯥ ꯀꯟꯇꯦꯛꯇ ꯇꯧꯗ꯭ꯔꯤꯉꯩ ꯃꯃꯥꯡꯗꯥ, ꯄ꯭ꯔꯗꯛꯇ ꯐꯦꯃꯤꯂꯤ, ꯁꯤꯖꯤꯟꯅꯅꯕꯥ ꯄꯥꯟꯗꯝ ꯊꯝꯂꯤꯕꯥ, ꯗꯦꯁ꯭ꯇꯤꯅꯦꯁꯟ ꯃꯥꯔꯀꯦꯠ, ꯗꯤꯚꯥꯏꯁ ꯀ꯭ꯂꯥꯁꯤꯐꯤꯀꯦꯁꯟ, ꯁ꯭ꯇꯦꯔꯤꯜ ꯅꯠꯠꯔꯒꯥ ꯅꯟ-ꯁ꯭ꯇꯦꯔꯤꯜ ꯁ꯭ꯇꯦꯇꯁ, ꯚꯣꯜꯌꯨꯝ ꯐꯣꯔꯀꯥꯁ꯭ꯠ, ꯃꯊꯧ ꯇꯥꯕꯥ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ, ꯄ꯭ꯔꯥꯏꯚꯦꯠ-ꯂꯦꯕꯦꯜ ꯁ꯭ꯀꯣꯞ, ꯑꯃꯁꯨꯡ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯅꯒꯤ ꯊꯧꯗꯥꯡꯁꯤꯡ ꯑꯗꯨ ꯗꯤꯐꯥꯏꯟ ꯇꯧ꯫ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯕꯨ ꯁꯦꯃꯗꯣꯛ-ꯁꯦꯃꯖꯤꯟ ꯇꯧꯗꯕꯥ ꯃꯊꯧ ꯇꯥꯕꯥ ꯑꯃꯒꯥ ꯃꯥꯟꯅꯅꯥ ꯏꯚꯥꯜꯌꯨꯑꯦꯠ ꯇꯧꯕꯥ ꯌꯥꯗꯦ꯫

1ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯁꯤꯁ꯭ꯇꯦꯝ, ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯁ꯭ꯇꯦꯇꯁ, ꯑꯃꯁꯨꯡ ꯑꯣꯗꯤꯠ ꯔꯦꯗꯤꯑꯣ꯫

ꯑꯥꯏꯅꯒꯤ ꯑꯣꯏꯕꯥ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯑꯃꯁꯨꯡ ꯃꯔꯨꯑꯣꯏꯕꯥ ꯊꯕꯛ ꯊꯧꯔꯃꯁꯤꯡ ꯄꯥꯡꯊꯣꯛꯂꯤꯕꯥ ꯁꯥꯏꯠ ꯈꯨꯗꯤꯡꯃꯛ ꯃꯁꯛ ꯈꯪꯗꯣꯛꯇꯨꯅꯥ ꯍꯧꯒꯗꯕꯅꯤ꯫ ꯗꯤꯖꯥꯏꯟ, ꯃꯦꯁꯤꯟ, ꯐꯤꯅꯤꯁꯤꯡ, ꯁꯦꯡꯗꯣꯀꯄꯥ, ꯄꯦꯀꯦꯖꯤꯡ, ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ, ꯂꯦꯕꯦꯂꯤꯡ, ꯔꯤꯂꯤꯖ, ꯀꯃꯞꯂꯦꯟꯇ ꯍꯦꯟꯗꯜ ꯇꯧꯕꯥ, ꯑꯃꯁꯨꯡ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯁꯕꯃꯤꯁꯅꯁꯤꯡ ꯀꯅꯥꯅꯥ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯂꯦꯄꯊꯣꯀꯄꯥ꯫

ꯍꯧꯖꯤꯛ ꯂꯩꯔꯤꯕꯥ ISO 13485 ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯑꯗꯨ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧ ꯑꯃꯁꯨꯡ ꯑꯣꯔꯒꯥꯅꯥꯏꯖꯦꯁꯅꯒꯤ ꯃꯃꯤꯡ, ꯑꯦꯗ꯭ꯔꯦꯁ, ꯁ꯭ꯀꯣꯞ, ꯏꯁꯨ ꯇꯧꯔꯤꯕꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯕꯣꯗꯤ, ꯑꯦꯛꯔꯦꯗꯤꯇꯦꯁꯟ, ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯀꯤ ꯁ꯭ꯇꯦꯇꯁ, ꯑꯃꯁꯨꯡ ꯃꯇꯝ ꯂꯣꯌꯔꯕꯥ ꯑꯗꯨ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧ꯫ ꯌꯨ.ꯑꯦꯁ.ꯀꯤ ꯁꯞꯂꯥꯏꯒꯤꯗꯃꯛꯇꯥ, ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯑꯗꯨꯅꯥ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.ꯒꯤ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯑꯗꯨ ꯀꯔꯝꯅꯥ ꯏꯃꯞꯂꯤꯃꯦꯟꯇ ꯇꯧꯈꯤꯕꯒꯦ ꯍꯥꯌꯅꯥ ꯍꯪꯕꯤꯌꯨ꯫ ꯏꯌꯨ ꯁꯞꯂꯥꯏꯒꯤꯗꯃꯛꯇꯥ, ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯁ꯭ꯇꯦꯇꯁ ꯑꯃꯁꯨꯡ ꯏꯀꯣꯅꯣꯃꯤꯛ-ꯑꯣꯄꯔꯦꯇꯔꯒꯤ ꯊꯧꯗꯥꯡꯁꯤꯡ ꯀꯅꯐꯥꯔꯝ ꯇꯧ꯫

ꯑꯦꯛꯁ.ꯁꯤ.ꯃꯦꯗꯤꯀꯣꯅꯥ ꯃꯁꯤꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯑꯣꯚꯔꯚꯤꯌꯨ ꯑꯃꯥ ꯐꯣꯉꯗꯣꯛꯂꯤ꯫ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯀꯟꯠꯔꯣꯜ ꯑꯃꯁꯨꯡ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯄ꯭ꯔꯣꯁꯦꯁ ; ꯀ꯭ꯔꯦꯇꯥꯁꯤꯡꯅꯥ ꯍꯧꯖꯤꯀꯁꯨ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯅꯒꯤ ꯃꯇꯃꯗꯥ ꯄꯣꯠꯊꯣꯛ- ꯑꯃꯁꯨꯡ ꯁꯥꯏꯠ-ꯁ꯭ꯄꯦꯁꯤꯐꯤꯛ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯒꯗꯕꯅꯤ꯫

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯕꯥ ; ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ ꯱꯳꯴꯸꯵ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯂꯤꯒꯦꯜ ꯑꯦꯟꯇꯤꯇꯤ ꯑꯃꯁꯨꯡ ꯁꯥꯏꯠ ꯂꯤꯁ꯭ꯠ; ꯄ꯭ꯔꯗꯛꯇ ꯑꯣꯊꯣꯔꯥꯏꯖꯦꯁꯅꯒꯤ ꯁꯃꯖꯤꯟꯅꯐꯝ; ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯅꯧꯕꯥ ꯑꯣꯗꯤꯠꯀꯤ ꯁ꯭ꯀꯣꯞ; ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯃꯑꯣꯡꯗꯥ QMSR ꯅꯠꯠꯔꯒꯥ MDR ꯔꯦꯗꯤꯑꯣꯒꯤ ꯄ꯭ꯔꯃꯥꯟ꯫
ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ, ꯂꯦꯕꯦꯂꯁꯤꯡ, ꯗꯤꯛꯂꯥꯔꯦꯁꯅꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯀꯣꯇꯦꯁꯅꯁꯤꯡꯒꯤ ꯃꯔꯛꯇꯥ ꯃꯃꯤꯡ, ꯑꯦꯗ꯭ꯔꯦꯁ, ꯁ꯭ꯀꯣꯞ, ꯇꯥꯡꯁꯤꯡ, ꯄꯣꯠꯊꯣꯛ ꯏꯃꯨꯡꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡꯒꯤ ꯊꯧꯗꯥꯡꯁꯤꯡ ꯃꯦꯆ ꯇꯧ꯫
ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ 'ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯅꯥ ꯁꯔꯇꯤꯐꯥꯏꯗ ꯇꯧꯔꯕꯥ' ꯋꯥꯍꯩꯁꯤꯡ; ꯀ꯭ꯔꯣꯞ ꯇꯧꯔꯕꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ; ꯃꯤꯁꯃꯦꯠ ꯇꯧꯔꯕꯥ ꯁꯥꯏꯇꯁꯤꯡ; ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯑꯥꯏꯅꯒꯤ ꯑꯣꯏꯕꯥ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ; ꯂꯦꯄꯊꯣꯛꯂꯕꯥ ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ. ꯅꯠꯔꯒꯥ ꯆꯦꯟꯖ-ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯅꯒꯤ ꯊꯧꯑꯣꯡ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ꯫

2ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ-ꯔꯦꯗꯤ ꯄ꯭ꯔꯗꯛꯇ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯟ꯫

ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ ꯊꯦꯡꯊꯕꯥ ꯑꯁꯤ ꯑꯌꯥꯝꯕꯗꯤ ꯄ꯭ꯔꯗꯛꯁꯟ ꯀꯦꯄꯥꯁꯤꯇꯤꯒꯤ ꯃꯍꯨꯠꯇꯥ ꯃꯄꯨꯡ ꯐꯥꯗꯕꯥ, ꯂꯦꯞꯄꯥ ꯂꯩꯇꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯗꯕꯥ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯁꯤꯡꯅꯥ ꯊꯣꯀꯍꯅꯕꯅꯤ꯫ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯁꯤꯡ ꯑꯁꯤ ꯇꯨꯡꯗꯥ ꯁꯦꯝꯕꯥ ꯌꯥꯏ ꯍꯥꯌꯕꯒꯤ ꯋꯥꯁꯛ ꯑꯃꯥ ꯌꯥꯕꯒꯤ ꯃꯍꯨꯠꯇꯥ ꯔꯤꯞꯔꯖꯦꯟꯇꯦꯇꯤꯚ ꯄ꯭ꯔꯗꯛꯇ ꯐꯦꯃꯤꯂꯤ ꯑꯃꯥ ꯏꯚꯥꯜꯌꯨꯑꯦꯠ ꯇꯧꯕꯥ꯫

  • ꯗꯤꯚꯥꯏꯁꯀꯤ ꯃꯁꯛ ꯇꯥꯀꯄꯥ, ꯄꯥꯟꯗꯝ ꯊꯝꯂꯤꯕꯥ ꯄꯥꯟꯗꯝ, ꯃꯣꯗꯦꯂꯁꯤꯡ, ꯁꯥꯏꯖꯁꯤꯡ, ꯄꯣꯠꯊꯣꯛ ꯀꯣꯗꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯀꯝꯄꯦꯇꯤꯕꯤꯂꯤꯇꯤ ꯃꯦꯠꯔꯤꯛ;
  • ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯔꯤꯚꯤꯖꯟ ꯑꯃꯁꯨꯡ ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯂꯣꯂꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯂꯦꯕꯦꯜ ꯑꯃꯁꯨꯡ ꯏꯟꯁꯠꯔꯛꯁꯟ-ꯐꯣꯔ-ꯌꯨꯖ ꯇꯦꯃꯞꯂꯦꯠꯁꯤꯡ;
  • ꯃꯦꯇꯔꯤꯑꯦꯜ ꯁ꯭ꯄꯦꯁꯤꯐꯤꯀꯦꯁꯅꯁꯤꯡ, ꯗꯤꯛꯂꯥꯔꯦꯁꯅꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯃꯔꯤ ꯂꯩꯅꯕꯥ ꯕꯥꯏꯑꯣꯂꯣꯖꯤꯀꯦꯜ-ꯁꯦꯐꯇꯤ ꯏꯕꯤꯗꯦꯟꯁ;
  • ꯔꯤꯁ꯭ꯛ-ꯃꯦꯅꯦꯖꯃꯦꯟꯇ, ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ, ꯚꯦꯂꯤꯗꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯃꯐꯃꯗꯥ ꯀ꯭ꯂꯤꯅꯤꯀꯦꯜ ꯅꯠꯠꯔꯒꯥ ꯄꯔꯐꯣꯃꯦꯟꯁ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯟ;
  • ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ, ꯄꯦꯀꯦꯖꯤꯡ, ꯇ꯭ꯔꯥꯟꯁꯄꯣꯔꯠ, ꯁꯦꯂꯐ-ꯂꯥꯏꯐ, ꯑꯃꯁꯨꯡ ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯃꯑꯣꯡꯗꯥ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯅꯁꯤꯡ ꯑꯃꯨꯛ ꯍꯟꯅꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯇꯧꯕꯥ;
  • ꯇꯥꯔꯒꯦꯠ ꯃꯥꯔꯀꯦꯠꯀꯤꯗꯃꯛꯇꯥ ꯃꯊꯧ ꯇꯥꯕꯥ ꯀꯅꯐꯣꯔꯃꯤꯇꯤꯒꯤ ꯗꯤꯛꯂꯥꯔꯦꯁꯟ, ꯁꯔꯇꯤꯐꯤꯀꯦꯠ, ꯂꯤꯁ꯭ꯠ, ꯀ꯭ꯂꯤꯌꯔꯦꯟꯁ, ꯅꯠꯠꯔꯒꯥ ꯑꯣꯊꯣꯔꯥꯏꯖꯦꯁꯟ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ꯫

ꯑꯀꯛꯅꯕꯥ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ ꯄꯦꯀꯦꯖ ꯑꯗꯨꯒꯤꯗꯃꯛ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯇꯧꯔꯕꯥ ꯔꯦꯁ꯭ꯄꯣꯟꯁ ꯇꯥꯏꯝ ꯑꯃꯥ ꯌꯥꯅꯕꯥ꯫ ꯃꯄꯨꯡ ꯐꯥꯕꯥ, ꯂꯦꯞꯄꯥ ꯂꯩꯇꯕꯥ, ꯔꯤꯚꯤꯖꯟ ꯀꯟꯠꯔꯣꯜ, ꯑꯃꯁꯨꯡ ꯑꯣꯅꯔꯁꯤꯞ ꯃꯥꯄꯜ-ꯈꯣꯡꯖꯦꯜ ꯈꯛꯇꯅꯥ ꯅꯠꯇꯦ꯫

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯃꯔꯤ ꯂꯩꯅꯕꯥ ꯄ꯭ꯔꯗꯛꯇ ꯐꯦꯃꯤꯂꯤ ꯑꯃꯒꯤ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯁꯦꯝꯄꯜ ꯗꯣꯁꯤꯌꯔ ꯑꯃꯥ, ꯃꯁꯤꯒꯤ ꯃꯊꯛꯇꯥ ꯃꯄꯨ, ꯔꯤꯚꯤꯖꯟ, ꯑꯦꯞꯔꯨꯚ ꯇꯧꯕꯒꯤ ꯇꯥꯡ, ꯑꯃꯁꯨꯡ ꯁꯦꯌꯔ ꯇꯧꯕꯒꯤ ꯑꯊꯤꯡꯕꯁꯤꯡ ꯎꯠꯂꯤꯕꯥ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯏꯟꯗꯦꯛꯁ ꯑꯃꯥ꯫
ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ꯫ꯗ꯭ꯔꯣꯏꯪ, ꯇꯦꯁ꯭ꯠ ꯔꯤꯄꯣꯔꯇꯁꯤꯡ, ꯂꯦꯕꯦꯂꯁꯤꯡ, ꯑꯥꯏ.ꯑꯦꯐ.ꯌꯨ.ꯁꯤꯡ, ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ, ꯗꯤꯛꯂꯥꯔꯦꯁꯅꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯗꯛꯇ ꯃꯥꯁ꯭ꯇꯔ ꯗꯦꯇꯥꯒꯤ ꯃꯔꯛꯇꯥ ꯀ꯭ꯔꯣꯁ-ꯆꯦꯛ ꯑꯥꯏꯗꯦꯟꯇꯤꯐꯥꯌꯔꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯔꯤꯚꯤꯖꯅꯁꯤꯡ
ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ ꯗꯣꯀꯨꯃꯦꯟꯇ ꯏꯟꯗꯦꯛꯁ ꯂꯩꯇꯦ; ꯌꯥꯅꯗꯕꯥ ꯄꯣꯠꯊꯣꯛ ꯀꯣꯗꯁꯤꯡ; ꯀꯟꯠꯔꯣꯜ ꯇꯧꯗꯕꯥ ꯐꯥꯏꯂꯁꯤꯡ; ꯖꯦꯅꯦꯔꯦꯜ ꯇꯦꯁ꯭ꯠ ꯔꯤꯄꯣꯔꯇꯁꯤꯡ; ꯀ꯭ꯌꯨ.ꯑꯦ./ꯑꯥꯔ.ꯑꯦ.ꯒꯤ ꯃꯄꯨ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; ꯇꯉꯥꯏꯐꯗꯕꯥ ꯄ꯭ꯔꯃꯥꯅꯒꯤꯗꯃꯛ 'ꯄꯔꯆꯦꯖ ꯇꯧꯔꯕꯥ ꯃꯇꯨꯡꯗꯥ ꯐꯪꯒꯅꯤ'꯫

3ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ, UDI/EUDAMED ꯗꯦꯇꯥ, ꯑꯃꯁꯨꯡ ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ꯫

ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ ꯁꯤꯁ꯭ꯇꯦꯝ ꯑꯃꯅꯥ ꯂꯣꯏꯁꯤꯜꯂꯕꯥ ꯏꯃꯞꯂꯥꯟꯇ ꯅꯠꯠꯔꯒꯥ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇ ꯑꯃꯕꯨ ꯔꯣ ꯃꯦꯇꯔꯤꯌꯦꯂꯁꯤꯡ, ꯄ꯭ꯔꯗꯛꯁꯟ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ, ꯏꯟꯁꯄꯦꯛꯁꯅꯁꯤꯡ, ꯑꯥꯎꯠꯁꯣꯔꯁ ꯇꯧꯔꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡ, ꯂꯦꯕꯦꯂꯤꯡ, ꯄꯦꯀꯦꯖꯤꯡ, ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯃꯐꯃꯗꯥ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯔꯤꯂꯤꯖ ꯇꯧꯕꯒꯥ ꯁꯝꯅꯍꯅꯒꯗꯕꯅꯤ꯫ ꯂꯣꯠ ꯑꯃꯥ ꯈꯅꯗꯨꯅꯥ ꯑꯃꯁꯨꯡ ꯐꯣꯔꯋꯥꯔꯗ-ꯑꯦꯟꯗ-ꯕꯦꯀꯋꯥꯔꯗ ꯇ꯭ꯔꯦꯁ ꯑꯃꯥ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯗꯨꯅꯥ ꯁꯤꯁ꯭ꯇꯦꯝ ꯑꯗꯨ ꯇꯦꯁ꯭ꯠ ꯇꯧ꯫

ꯏ.ꯌꯨ.ꯒꯤ ꯄꯣꯠꯊꯣꯀꯁꯤꯡꯒꯤ ꯑꯣꯏꯅꯗꯤ, ꯃꯦꯟꯗꯦꯇꯔꯤ ꯏ.ꯌꯨ.ꯗꯤ.ꯑꯦ.ꯑꯦꯝ.ꯏ.ꯗꯤ.ꯒꯤ ꯃꯣꯗ꯭ꯌꯨꯂꯁꯤꯡꯒꯤ ꯀꯟꯇꯦꯛꯁꯇꯥ ꯑꯦꯛꯇꯔ, ꯌꯨ.ꯗꯤ.ꯑꯥꯏ./ꯗꯤꯚꯥꯏꯁ, ꯁꯔꯇꯤꯐꯤꯀꯦꯠ, ꯑꯃꯁꯨꯡ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔꯒꯤ ꯗꯦꯇꯥꯁꯤꯡ ꯌꯦꯡꯁꯤꯅꯕꯤꯌꯨ꯫ ꯑꯇꯣꯞꯄꯥ ꯀꯩꯊꯦꯂꯁꯤꯡꯒꯤ ꯑꯣꯏꯅꯗꯤ, ꯃꯔꯤ ꯂꯩꯅꯕꯥ UDI ꯀꯦꯔꯤꯌꯔ, ꯏꯁꯨ ꯇꯧꯔꯤꯕꯥ ꯑꯦꯖꯦꯟꯁꯤ, ꯗꯦꯇꯥꯕꯦꯖ, ꯑꯃꯁꯨꯡ ꯂꯣꯀꯦꯜ ꯂꯦꯕꯦꯂꯤꯡꯒꯤ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯑꯗꯨ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧ꯫ UDI ꯔꯦꯗꯤꯑꯣ ꯑꯁꯤ ꯂꯦꯖꯔ ꯃꯥꯔꯀꯤꯡꯗꯒꯤ ꯍꯦꯟꯅꯥ ꯋꯥꯡꯏ: ꯑꯥꯏꯗꯦꯟꯇꯤꯐꯥꯌꯔ ꯑꯃꯁꯨꯡ ꯗꯦꯇꯥꯕꯦꯖ ꯔꯦꯀꯣꯔꯗ ꯑꯁꯤ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯗꯤꯚꯥꯏꯁ ꯃꯥꯁ꯭ꯇꯔ ꯗꯦꯇꯥꯒꯥ ꯃꯥꯟꯅꯒꯗꯕꯅꯤ꯫

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯕꯥ ꯂꯣꯠ-ꯇ꯭ꯔꯦꯁꯀꯤ ꯈꯨꯗꯝ; ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯁ꯭ꯠꯔꯀꯆꯔ; ꯗꯤꯚꯥꯏꯁ ꯃꯥꯁ꯭ꯇꯔ ꯗꯦꯇꯥ; ꯂꯦꯕꯦꯂꯤꯡ ꯑꯦꯞꯔꯨꯕꯦꯜ ꯇꯧꯕꯥ; ꯔꯤꯇꯦꯟꯁꯅꯒꯤ ꯀꯥꯡꯂꯣꯅꯁꯤꯡ; ꯀꯃꯞꯂꯦꯟꯇ/ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ.ꯒꯤ ꯐ꯭ꯂꯣ; ꯀꯁ꯭ꯇꯃꯔ ꯆꯦꯟꯖ-ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯅꯒꯤ ꯊꯧꯑꯣꯡ꯫
ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯇ꯭ꯔꯦꯏꯁ ꯑꯦꯛꯁꯔꯁꯥꯏꯖ ꯑꯃꯥ ꯆꯠꯊꯕꯥ ꯑꯃꯁꯨꯡ ꯃꯦꯇꯔꯤꯑꯦꯜ, ꯁꯞꯂꯥꯏꯌꯔ, ꯀꯣꯇꯤꯡ, ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ, ꯄꯦꯀꯦꯖꯤꯡ, ꯂꯦꯕꯦꯜ, ꯁꯣꯐꯇꯋꯥꯌꯔ, ꯅꯠꯠꯔꯒꯥ ꯗꯥꯏꯃꯦꯟꯁꯅꯒꯤ ꯑꯍꯣꯡꯕꯁꯤꯡ ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯑꯦꯁꯦꯁ ꯇꯧꯕꯒꯦ ꯑꯃꯁꯨꯡ ꯄꯥꯎ ꯐꯥꯎꯗꯣꯀꯄꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯌꯦꯡꯁꯤꯜꯂꯨ꯫
ꯔꯦꯗ ꯐ꯭ꯂꯦꯒꯁꯤꯡ ; ꯇ꯭ꯔꯦꯁ ꯃꯦꯊꯗ ꯑꯃꯠꯇꯥ ꯌꯥꯑꯣꯗꯅꯥ 'ꯑꯩꯈꯣꯌꯅꯥ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ ꯊꯝꯂꯤ' UDI ꯗꯦꯇꯥ ꯑꯁꯤ ꯂꯦꯕꯦꯂꯁꯤꯡꯒꯥ ꯃꯥꯟꯅꯗꯦ; ꯀꯁ꯭ꯇꯃꯔ ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯟ ꯌꯥꯑꯣꯗꯅꯥ ꯑꯍꯣꯡꯕꯥ ꯄꯨꯔꯀꯄꯥ ꯌꯥꯏ; ꯂꯣꯠ ꯂꯤꯉ꯭ꯀꯦꯖ ꯂꯩꯇꯕꯥ꯫

4ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤ ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯣꯁꯦꯁ ꯚꯦꯂꯤꯗꯦꯁꯟ꯫

ꯄ꯭ꯔꯗꯛꯇ ꯀꯦꯇꯥꯂꯣꯒ ꯑꯃꯅꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯅꯥ ꯅꯍꯥꯛꯀꯤ ꯗꯤꯚꯥꯏꯁꯀꯤꯗꯃꯛꯇꯥ ꯃꯊꯧ ꯇꯥꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡ ꯑꯗꯨ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯏ ꯍꯥꯌꯕꯁꯤ ꯄ꯭ꯔꯃꯥꯟ ꯇꯧꯗꯦ꯫ ꯃꯦꯁꯤꯟ ꯇꯧꯕꯥ, ꯐꯣꯔꯖꯤꯡ, ꯍꯤꯠ ꯇ꯭ꯔꯤꯠꯃꯦꯟꯇ, ꯋꯦꯜꯗꯤꯡ, ꯄꯣꯂꯤꯁꯤꯡ, ꯄꯦꯁꯤꯐꯤꯀꯦꯁꯟ, ꯀꯣꯇꯤꯡ, ꯁꯦꯡꯗꯣꯀꯄꯥ, ꯑꯦꯁꯦꯝꯕꯂꯤ, ꯄꯦꯀꯦꯖꯤꯡ, ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯑꯔꯣꯏꯕꯥ ꯌꯦꯡꯁꯤꯅꯕꯒꯤ ꯈꯨꯠꯊꯥꯡꯗꯥ ꯄ꯭ꯔꯄꯣꯖ ꯇꯧꯔꯤꯕꯥ ꯄꯣꯠꯊꯣꯛ ꯑꯗꯨ ꯃꯦꯞ ꯇꯧ꯫ ꯀꯔꯝꯕꯥ ꯑꯣꯄꯔꯦꯁꯅꯁꯤꯡ ꯑꯗꯨ ꯏꯟ-ꯍꯥꯎꯁꯇꯥ ꯄꯥꯡꯊꯣꯀꯄꯒꯦ ꯑꯃꯁꯨꯡ ꯀꯔꯝꯕꯥ ꯑꯥꯎꯠꯁꯣꯔꯁ ꯇꯧꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯈꯪꯗꯣꯀꯄꯥ꯫

ꯁꯞꯂꯥꯏꯌꯔꯒꯤ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ꯫ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤꯁꯤꯡ , ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯃꯈꯣꯌꯁꯤꯡ ꯑꯁꯤ ꯏꯛꯕꯤꯄꯃꯦꯟꯇ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ, ꯑꯣꯄꯔꯦꯇꯔꯒꯤ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯅꯁꯤꯡ, ꯄ꯭ꯔꯣꯁꯦꯁ ꯚꯦꯂꯤꯗꯦꯁꯟ, ꯃꯦꯟꯇꯦꯅꯦꯟꯁ, ꯀꯦꯂꯤꯕ꯭ꯔꯦꯁꯟ, ꯏꯟꯁꯄꯦꯛꯁꯟ ꯃꯦꯊꯗꯁꯤꯡ, ꯅꯟ-ꯀꯅꯐꯣꯔꯃꯦꯟꯁ ꯍꯦꯟꯗꯜ ꯇꯧꯕꯥ, ꯑꯃꯁꯨꯡ ꯇꯁꯦꯡꯕꯥ ꯕꯦꯆ ꯔꯦꯀꯣꯔꯗꯁꯤꯡꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯏ꯫

ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯅꯥ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ ꯒꯦꯠ ꯑꯗꯨ ꯄꯥꯁ ꯇꯧꯔꯕꯥ ꯃꯇꯨꯡꯗꯥ, ꯀ ꯔꯤꯁ꯭ꯛ-ꯑꯦꯗꯖꯁ꯭ꯇꯦꯗ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯀꯣꯁ꯭ꯠ ꯃꯣꯗꯦꯜ꯫ ꯌꯨꯅꯤꯠꯀꯤ ꯃꯃꯜ ꯈꯛꯇꯒꯤ ꯃꯍꯨꯠꯇꯥ

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯄ꯭ꯔꯣꯁꯦꯁ ꯐ꯭ꯂꯣ; ꯏꯛꯕꯤꯄꯃꯦꯟꯇ ꯂꯤꯁ꯭ꯠ; ꯚꯦꯂꯤꯗꯦꯁꯅꯒꯤ ꯋꯥꯔꯣꯜ; ꯀꯦꯂꯤꯕ꯭ꯔꯦꯁꯅꯒꯤ ꯐꯤꯚꯝ; ꯃꯔꯨꯑꯣꯏꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ; ꯏꯟꯁꯄꯦꯛꯁꯟ ꯄ꯭ꯂꯥꯟ; ꯍꯟꯗꯛꯀꯤ ꯔꯤꯞꯔꯖꯦꯟꯇꯦꯇꯤꯕ ꯕꯦꯆ ꯔꯦꯀꯣꯔꯗ꯫
ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯐꯦꯁꯤꯂꯤꯇꯤ ꯑꯗꯨꯒꯤ ꯈꯨꯠꯊꯥꯡꯗꯥ ꯑꯁꯦꯡꯕꯥ ꯄꯣꯠꯊꯣꯛ ꯑꯃꯥ ꯐꯣꯂꯣ ꯇꯧ꯫ ꯇꯣꯂꯔꯦꯟꯁ ꯑꯃꯁꯨꯡ ꯑꯦꯛꯁꯦꯞꯇꯦꯟꯁ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥꯁꯤꯡ ꯑꯁꯤ ꯊꯥꯖꯕꯥ ꯌꯥꯅꯥ ꯂꯦꯄꯊꯣꯀꯄꯥ ꯌꯥꯏ ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯗꯛꯁꯟ ꯚꯣꯜꯌꯨꯃꯗꯥ ꯍꯟꯖꯤꯟ ꯍꯟꯖꯤꯟ ꯇꯧꯕꯥ ꯌꯥꯏ ꯍꯥꯌꯕꯥ ꯀꯅꯐꯥꯔꯝ ꯇꯧꯕꯥ꯫
ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ ꯃꯁꯛ ꯈꯉꯗꯕꯥ ꯑꯥꯎꯠꯁꯣꯔꯁꯤꯡ; ꯁ꯭ꯄꯦꯁꯤꯑꯦꯜ-ꯄ꯭ꯔꯣꯁꯦꯁ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯂꯩꯇꯕꯥ; ꯏꯟꯁꯄꯦꯛꯁꯟ ꯑꯁꯤ ꯚꯤꯖꯨꯑꯦꯜ ꯖꯖꯃꯦꯟꯇ ꯈꯛꯇꯗꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏ; ꯃꯇꯝ ꯂꯣꯏꯔꯕꯥ ꯀꯦꯂꯤꯕ꯭ꯔꯦꯁꯟ; ꯗꯣꯀꯨꯃꯦꯟꯇ ꯂꯩꯇꯕꯥ ꯔꯤꯋꯥꯔꯛ ꯅꯠꯠꯔꯒꯥ ꯗꯦꯕꯤꯌꯦꯁꯅꯁꯤꯡ꯫

5ꯂꯤꯗ ꯇꯥꯏꯝ, ꯏꯅꯚꯦꯟꯇꯔꯤ, ꯑꯃꯁꯨꯡ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ ꯔꯤꯂꯤꯑꯦꯕꯤꯂꯤꯇꯤ꯫

ꯄꯥꯛ-ꯆꯥꯎꯔꯕꯥ ꯋꯥꯁꯀꯁꯤꯡ ꯑꯗꯨ ꯃꯥꯄꯂꯒꯤ ꯑꯣꯏꯕꯥ ꯋꯥꯍꯟꯊꯣꯀꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯃꯍꯨꯠ ꯁꯤꯅꯕꯥ꯫ ꯅꯣꯔꯃꯦꯜ ꯑꯃꯁꯨꯡ ꯄꯤꯛ ꯀꯦꯄꯥꯁꯤꯇꯤ, ꯄ꯭ꯔꯗꯛꯇ ꯐꯦꯃꯤꯂꯤꯒꯤ ꯃꯇꯨꯡꯏꯟꯅꯥ ꯂꯤꯗ ꯇꯥꯏꯃꯁꯤꯡ, ꯑꯣꯔꯗꯔ-ꯀꯅꯐꯔꯃꯦꯁꯟ ꯇꯥꯏꯃꯤꯡ, ꯃꯤꯅꯤꯃꯝ ꯑꯣꯔꯗꯔ ꯀ꯭ꯕꯥꯟꯇꯤꯇꯤꯁꯤꯡ, ꯁ꯭ꯇꯣꯛ ꯁ꯭ꯇꯦꯇꯁ, ꯐꯣꯔꯀꯥꯁ꯭ꯇꯀꯤ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ, ꯐꯤꯜ ꯔꯦꯠ ꯅꯠꯠꯔꯒꯥ OTIF ꯀꯦꯂꯀꯨꯂꯦꯁꯟ, ꯗꯦꯂꯤ ꯑꯦꯁ꯭ꯀꯦꯂꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯔꯤꯀꯣꯚꯔꯤ ꯄ꯭ꯂꯥꯅꯁꯤꯡꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯍꯪꯕꯤꯌꯨ꯫

ꯔꯤꯖꯅꯦꯜ ꯋꯦꯌꯔꯍꯥꯎꯁꯤꯡꯅꯥ ꯔꯤꯞꯂꯦꯅꯤꯡ ꯇꯧꯕꯒꯤ ꯃꯇꯝ ꯍꯟꯊꯍꯅꯕꯥ ꯌꯥꯏ, ꯑꯗꯨꯕꯨ ꯐꯦꯁꯤꯂꯤꯇꯤꯒꯤ ꯑꯦꯗ꯭ꯔꯦꯁ, ꯁ꯭ꯇꯣꯛ ꯇꯧꯔꯕꯥ SKUꯁꯤꯡ, ꯏꯅꯚꯦꯟꯇꯔꯤ ꯑꯣꯅꯔꯁꯤꯞ, ꯔꯤꯄꯣꯔꯠ ꯇꯧꯕꯒꯤ ꯐ꯭ꯔꯤꯛꯕꯦꯟꯁꯤ, ꯔꯤꯇꯔꯟ ꯄ꯭ꯔꯣꯁꯦꯁ, ꯑꯦꯅꯚꯥꯏꯔꯅꯃꯦꯟꯇ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ, ꯄꯦꯀꯦꯖꯤꯡ-ꯏꯟꯇꯤꯒ꯭ꯔꯤꯇꯤ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯁꯔꯚꯤꯁ-ꯂꯦꯚꯦꯜ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇ ꯑꯗꯨ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧ꯫ ꯔꯤꯚꯤꯌꯨ ꯑꯦꯛꯁꯁꯤ ꯃꯦꯗꯤꯀꯣꯒꯤ ꯐꯣꯉꯈ꯭ꯔꯦ꯫ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏ-ꯆꯦꯟ ꯑꯃꯁꯨꯡ ꯋꯦꯌꯔꯍꯥꯎꯁꯤꯡ ꯃꯣꯗꯦꯜ ꯑꯁꯤ ꯏꯅꯄꯨꯠ ꯑꯃꯥ ꯑꯣꯏꯅꯥ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯍꯟꯗꯛꯀꯤ ꯄꯔꯐꯣꯃꯦꯟꯁ ꯏꯕꯤꯗꯦꯟꯁꯁꯤꯡ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯕꯥ꯫

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯕꯥ ꯂꯤꯗ-ꯇꯥꯏꯝ ꯃꯦꯠꯔꯤꯛ; ꯁ꯭ꯇꯣꯛ ꯁ꯭ꯅꯦꯄꯁꯣꯠ; ꯀꯦꯄꯥꯁꯤꯇꯤꯒꯤ ꯑꯋꯥꯠꯄꯥ ꯂꯩꯕꯥ; ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.ꯀꯤ ꯋꯥꯍꯟꯊꯣꯛ ꯑꯃꯁꯨꯡ ꯍꯟꯗꯛꯀꯤ ꯇ꯭ꯔꯦꯟꯗ; ꯁꯤꯄꯤꯡ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ; ꯀꯟꯇꯤꯟꯖꯦꯟꯁꯤ ꯑꯃꯁꯨꯡ ꯕꯤꯖꯤꯅꯦꯁ-ꯀꯟꯇꯤꯟꯌꯨꯏꯇꯤ ꯄ꯭ꯂꯥꯟ꯫
ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯔꯤꯞꯔꯖꯦꯟꯇꯦꯇꯤꯕ ꯑꯣꯔꯗꯔꯁꯤꯡꯗꯥ ꯋꯥꯁꯀꯈꯤꯕꯥ ꯑꯃꯁꯨꯡ ꯇꯁꯦꯡꯕꯥ ꯇꯥꯡꯁꯤꯡ ꯆꯥꯡꯗꯝꯅꯕꯥ꯫ ꯑꯋꯥꯠꯄꯥ, ꯈꯨꯗꯛꯀꯤ ꯑꯣꯏꯕꯥ ꯑꯣꯔꯗꯔꯁꯤꯡ, ꯀꯁ꯭ꯇꯃꯁ ꯊꯦꯡꯊꯕꯥ, ꯔꯤꯇꯔꯟ, ꯑꯃꯁꯨꯡ ꯁꯦꯠ ꯔꯤꯞꯂꯦꯅꯤꯡ ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯍꯦꯟꯗꯜ ꯇꯧꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯀꯅꯐꯥꯔꯝ ꯇꯧ꯫
ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ ꯄꯣꯠꯊꯣꯛ ꯈꯨꯗꯤꯡꯃꯛꯀꯤ ꯂꯤꯗ ꯇꯥꯏꯝ ꯑꯃꯥ; 'ꯃꯇꯝ ꯄꯨꯝꯕꯗꯥ ꯁ꯭ꯇꯣꯛꯇꯥ ꯂꯩꯔꯤ'; ꯑꯦꯁ.ꯀꯦ.ꯌꯨ.-ꯂꯦꯕꯦꯜ ꯗꯦꯇꯥ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; ꯑꯦꯁ꯭ꯀꯦꯂꯦꯁꯟ ꯑꯣꯅꯔ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯏꯅꯚꯦꯟꯇꯔꯤ ꯔꯤꯁ꯭ꯛ; ꯁꯄꯣꯔꯠ ꯇꯧꯗꯕꯥ ꯗꯦꯂꯤꯚꯔꯤ ꯀ꯭ꯂꯦꯃꯁꯤꯡ꯫

6ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ.ꯒꯤ ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯦꯝꯄꯜ ꯚꯦꯂꯤꯗꯦꯁꯟ꯫

ꯀꯁ꯭ꯇꯃꯔꯥꯏꯖꯦꯁꯟ ꯑꯁꯤ ꯄ꯭ꯔꯥꯏꯕꯦꯠ-ꯂꯦꯕꯦꯜ ꯄꯦꯀꯦꯖꯤꯡꯗꯒꯤ ꯍꯧꯔꯒꯥ ꯑꯅꯧꯕꯥ ꯏꯃꯞꯂꯥꯟꯇ ꯅꯠꯔꯒꯥ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇ ꯐꯥꯑꯣꯕꯥ ꯌꯥꯑꯣꯔꯤ꯫ ꯕ꯭ꯔꯥꯟꯗꯤꯡ, ꯁꯦꯠ ꯀꯟꯐꯤꯒꯔꯦꯁꯟ, ꯗꯥꯏꯃꯦꯟꯁꯟ ꯃꯣꯗꯤꯐꯤꯀꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯑꯅꯧꯕꯥ-ꯄ꯭ꯔꯗꯛꯇ ꯗꯤꯕꯦꯂꯄꯃꯦꯟꯇꯀꯤ ꯇꯣꯉꯥꯟ ꯇꯣꯉꯥꯅꯕꯥ ꯊꯥꯛꯀꯤ ꯗꯤꯖꯥꯏꯟ ꯀꯟꯠꯔꯣꯜ ꯑꯃꯁꯨꯡ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯑꯦꯁꯦꯁꯃꯦꯟꯇ ꯃꯊꯧ ꯇꯥꯏ꯫

ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔꯒꯤ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ꯫ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ.ꯒꯤ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯋꯥꯔꯀꯐ꯭ꯂꯣ . ꯗꯤꯕꯦꯂꯄꯃꯦꯟꯇ ꯑꯌꯥꯕꯥ ꯄꯤꯗ꯭ꯔꯤꯉꯩꯒꯤ ꯃꯃꯥꯡꯗꯥ ꯒꯣꯄꯟ ꯑꯣꯏꯕꯥ, ꯗꯤꯖꯥꯏꯟ ꯑꯣꯅꯔꯁꯤꯞ, ꯇꯨꯂꯤꯡ ꯑꯣꯅꯔꯁꯤꯞ, ꯗꯤꯖꯥꯏꯟ ꯏꯅꯄꯨꯠꯁꯤꯡ, ꯔꯤꯁ꯭ꯛ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ, ꯗ꯭ꯔꯣꯏꯪ, ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ, ꯚꯦꯂꯤꯗꯦꯁꯟ, ꯗꯤꯖꯥꯏꯟ ꯇ꯭ꯔꯥꯟꯁꯐꯔ, ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ, ꯑꯃꯁꯨꯡ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯔꯦꯁ꯭ꯄꯣꯟꯁꯤꯕꯤꯂꯤꯇꯤꯁꯤꯡ ꯂꯦꯄꯊꯣꯀꯄꯥ꯫

ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯄꯥꯏꯂꯣꯠ ꯑꯃꯥ ꯆꯂꯥꯏꯕꯥ꯫ ꯁꯦꯝꯄꯜ ꯄ꯭ꯂꯥꯟ ꯑꯗꯨꯗꯥ ꯗ꯭ꯔꯣꯏꯪ ꯔꯤꯚꯤꯖꯟ, ꯃꯦꯇꯔꯤꯑꯦꯜ, ꯀ꯭ꯔꯤꯇꯤꯀꯦꯜ ꯗꯥꯏꯃꯦꯟꯁꯅꯁꯤꯡ, ꯐꯉ꯭ꯀꯁꯅꯦꯜ ꯑꯃꯁꯨꯡ ꯏꯟꯇꯔꯐꯦꯁ ꯇꯦꯁ꯭ꯇꯁꯤꯡ, ꯑꯦꯛꯁꯦꯞꯇꯦꯟꯁ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ, ꯁꯦꯝꯄꯂꯒꯤ ꯃꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯑꯦꯞꯔꯨꯚ ꯇꯧꯔꯕꯥ ꯁꯦꯝꯄꯜ ꯑꯗꯨ ꯀꯔꯝꯅꯥ ꯄ꯭ꯔꯗꯛꯁꯟ ꯃꯥꯁ꯭ꯇꯔ ꯑꯣꯏꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯐꯣꯡꯗꯣꯛꯀꯗꯕꯅꯤ꯫ ꯑꯍꯦꯅꯕꯥ ꯒꯥꯏꯗꯂꯥꯏꯅꯁꯤꯡ ꯏꯪꯂꯤꯁꯇꯥ ꯐꯪꯒꯅꯤ꯫ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ.ꯒꯤ ꯄ꯭ꯔꯣꯛꯌꯨꯔꯃꯦꯟꯇ ꯒꯥꯏꯗ꯫.

ꯑꯦꯟ.ꯗꯤ.ꯑꯦ.ꯗꯥ ꯍꯥꯌꯖꯔꯀꯄꯥ ; ꯄ꯭ꯔꯣꯖꯦꯛꯇ ꯄ꯭ꯂꯥꯟ; ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡꯒꯤ ꯃꯄꯨ; ꯑꯌꯥꯕꯥ ꯄꯤꯔꯕꯥ ꯗ꯭ꯔꯣꯏꯪꯁꯤꯡ; ꯗꯤ.ꯑꯦꯐ.ꯑꯦꯝ.ꯒꯤ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ; ꯔꯤꯁ꯭ꯛ ꯑꯃꯁꯨꯡ ꯇꯦꯁ꯭ꯠ ꯄ꯭ꯂꯥꯟ; ꯁꯦꯝꯄꯜ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯔꯤꯄꯣꯔꯠ; ꯍꯣꯡꯗꯣꯀꯄꯥ ꯑꯃꯁꯨꯡ ꯑꯃꯨꯛ ꯍꯟꯅꯥ ꯚꯦꯂꯤꯗꯦꯠ ꯇꯧꯕꯒꯤ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ꯫
ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯃꯦꯖꯔ ꯀꯝꯝꯌꯨꯅꯤꯀꯦꯁꯟ ꯀ꯭ꯕꯥꯂꯤꯇꯤ, ꯔꯤꯚꯤꯖꯟ ꯗꯤꯁꯤꯞꯂꯤꯟ, ꯁꯦꯝꯄꯜ ꯀꯅꯐꯣꯔꯃꯤꯇꯤ, ꯐꯥꯔꯁ꯭ꯠ-ꯄ꯭ꯔꯗꯛꯁꯟ-ꯂꯣꯠ ꯔꯤꯄꯤꯇꯦꯕꯤꯂꯤꯇꯤ, ꯑꯃꯁꯨꯡ ꯐꯦꯏꯜ ꯇꯧꯔꯕꯥ ꯇꯦꯁ꯭ꯇꯁꯤꯡ ꯅꯠꯠꯔꯒꯥ ꯗꯤꯖꯥꯏꯅꯒꯤ ꯑꯍꯣꯡꯕꯁꯤꯡ ꯍꯦꯟꯗꯜ ꯇꯧꯕꯥ꯫
ꯔꯦꯗ ꯐ꯭ꯂꯦꯒꯁꯤꯡ ꯁꯦꯂꯁ-ꯑꯣꯅꯂꯤ ꯇꯦꯛꯅꯤꯀꯦꯜ ꯀꯝꯝꯌꯨꯅꯤꯀꯦꯁꯟ; ꯑꯌꯥꯕꯥ ꯄꯤꯔꯕꯥ ꯗ꯭ꯔꯣꯏꯪ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; ꯀꯟꯠꯔꯣꯜ ꯇꯧꯗꯕꯥ ꯁꯦꯝꯄꯜ ꯍꯣꯡꯗꯣꯀꯄꯥ; ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ ꯄ꯭ꯂꯥꯟ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯕꯥ; ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ IP ꯅꯠꯠꯔꯒꯥ ꯇꯨꯂꯤꯡ ꯑꯣꯅꯔꯁꯤꯞ꯫

7ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ, ꯇ꯭ꯔꯦꯅꯤꯡ, ꯀꯃꯞꯂꯦꯟꯇꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯄꯣꯁ꯭ꯠ-ꯃꯥꯔꯀꯦꯠ ꯁꯄꯣꯔꯠ꯫

ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯝ ꯑꯃꯅꯥ ꯃꯁꯤꯒꯤ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ ꯑꯁꯤ ꯃꯄꯨꯡ ꯐꯥꯗꯕꯥ, ꯆꯨꯃꯊꯣꯀꯄꯥ ꯉꯃꯗꯕꯥ, ꯑꯃꯥꯡ-ꯑꯇꯥ ꯊꯣꯀꯄꯥ, ꯐꯪꯗꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯇꯧꯗꯕꯥ ꯃꯇꯃꯗꯥ ꯑꯣꯄꯔꯦꯁꯅꯦꯜ ꯑꯣꯏꯅꯥ ꯁꯣꯀꯍꯅꯕꯥ ꯌꯥꯏ꯫ ꯇ꯭ꯔꯦ ꯀꯟꯐꯤꯒꯔꯦꯁꯟ, ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇ-ꯇꯨ-ꯏꯃꯞꯂꯥꯟꯇ ꯀꯝꯄꯦꯇꯤꯕꯤꯂꯤꯇꯤ, ꯀꯥꯎꯟꯇ ꯁꯤꯠ, ꯔꯤꯞꯔꯣꯁꯦꯁꯤꯡꯒꯤ ꯏꯟꯁꯠꯔꯛꯁꯅꯁꯤꯡ, ꯏꯟꯁꯄꯦꯛꯁꯟ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ, ꯃꯍꯨꯠ ꯁꯤꯅꯕꯥ ꯌꯥꯕꯥ ꯁꯔꯨꯀꯁꯤꯡ, ꯔꯤꯄꯦꯌꯥꯔ ꯔꯨꯇꯁꯤꯡ, ꯔꯤꯞꯂꯦꯅꯤꯡ, ꯑꯃꯁꯨꯡ ꯇ꯭ꯔꯦꯅꯤꯡ ꯃꯦꯇꯔꯤꯑꯦꯂꯁꯤꯡ ꯏꯚꯥꯜꯌꯨꯑꯦꯠ ꯇꯧꯕꯥ꯫

ꯄꯣꯁ꯭ꯠ-ꯃꯥꯔꯀꯦꯠ ꯔꯦꯁ꯭ꯄꯣꯟꯁꯤꯕꯤꯂꯤꯇꯤꯁꯤꯡ ꯑꯁꯤꯅꯥ ꯀꯃꯞꯂꯦꯟꯇ ꯏꯅꯇꯦꯛ, ꯑꯦꯗꯚꯥꯟꯁ-ꯏꯚꯦꯟꯇ ꯑꯦꯁ꯭ꯀꯦꯂꯦꯁꯟ, ꯏꯅꯚꯦꯁ꯭ꯇꯤꯒꯦꯁꯟ, ꯔꯨꯠ-ꯀꯣꯖ ꯑꯦꯅꯥꯂꯥꯏꯁꯤꯁ, ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ., ꯇ꯭ꯔꯦꯟꯗ ꯔꯤꯄꯣꯔꯇꯤꯡ, ꯐꯤꯜꯗ ꯑꯦꯛꯁꯟ ꯅꯠꯠꯔꯒꯥ ꯔꯤꯀꯣꯜ ꯁꯄꯣꯔꯠ, ꯋꯥꯔꯦꯟꯇꯤ, ꯔꯤꯄꯦꯌꯔ, ꯑꯃꯁꯨꯡ ꯀꯝꯝꯌꯨꯅꯤꯀꯦꯁꯅꯒꯤ ꯃꯇꯃꯁꯤꯡ ꯑꯁꯤ ꯀꯣꯅꯁꯤꯅꯒꯗꯕꯅꯤ꯫ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯅꯥ ꯐꯣꯡꯈꯤꯕꯥ ꯑꯗꯨ ꯔꯤꯚꯤꯌꯨ ꯇꯧ꯫ ꯑꯥꯐꯇꯔ-ꯁꯦꯜ ꯑꯃꯁꯨꯡ ꯀꯃꯞꯂꯦꯟꯇ-ꯁꯄꯣꯔꯠ ꯄ꯭ꯔꯣꯁꯦꯁ , ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯑꯏꯕꯥ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯅꯠꯠꯔꯒꯥ ꯁꯞꯂꯥꯏ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇ ꯑꯃꯗꯥ ꯔꯦꯁ꯭ꯄꯣꯟꯁꯤꯕꯤꯂꯤꯇꯤꯁꯤꯡ ꯂꯦꯄꯊꯣꯀꯄꯥ꯫

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯕꯥ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇ ꯃꯦꯠꯔꯤꯛ; ꯇ꯭ꯔꯦ ꯂꯤꯁ꯭ꯠ; ꯑꯥꯏ.ꯑꯦꯐ.ꯌꯨ.; ꯇ꯭ꯔꯦꯅꯤꯡꯒꯤ ꯔꯤꯁꯣꯔꯁꯁꯤꯡ; ꯀꯃꯞꯂꯦꯟꯇ ꯐꯣꯔꯝ; ꯏꯅꯚꯦꯁ꯭ꯇꯤꯒꯦꯁꯅꯒꯤ ꯃꯇꯝ; ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ.ꯒꯤ ꯊꯧꯑꯣꯡ; ꯋꯥꯔꯦꯟꯇꯤ ꯄꯤꯕꯥ; ꯔꯤꯄꯦꯌꯔ ꯑꯃꯁꯨꯡ ꯔꯤꯞꯂꯦꯁꯃꯦꯟꯇꯀꯤ ꯇꯔꯃꯁꯤꯡ꯫
ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯃꯄꯨꯡꯐꯥꯕꯥ ꯁꯦꯠ ꯑꯃꯥ ꯌꯦꯡꯁꯤꯅꯕꯥ, ꯃꯥꯡꯈꯤꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯁꯣꯀꯍꯜꯂꯕꯥ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇ ꯀꯦꯁ ꯑꯃꯥ ꯁꯤꯃꯨꯂꯦꯠ ꯇꯧꯕꯥ, ꯑꯃꯁꯨꯡ ꯔꯤꯗꯦꯛꯇ ꯇꯧꯔꯕꯥ ꯀꯃꯞꯂꯦꯟꯇ ꯏꯅꯚꯦꯁ꯭ꯇꯤꯒꯦꯁꯟ ꯑꯃꯥ ꯅꯠꯠꯔꯒꯥ CAPA ꯏꯐꯦꯛꯇꯤꯕꯅꯦꯁꯀꯤ ꯈꯨꯗꯝ ꯑꯃꯥ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ꯫
ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯇ꯭ꯔꯦ ꯂꯤꯁ꯭ꯠ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯀꯝꯄꯦꯇꯤꯕꯤꯂꯤꯇꯤ; ꯃꯍꯨꯠ ꯁꯤꯅꯕꯥ ꯌꯥꯕꯥ ꯂꯝꯕꯤ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯀꯃꯞꯂꯦꯟꯇ ꯑꯣꯅꯔꯁꯤꯞ; ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ.ꯒꯤ ꯏꯐꯦꯛꯇꯤꯕꯅꯦꯁ ꯆꯦꯛ ꯅꯠꯔꯒꯥ ꯔꯤꯀꯣꯜ ꯁꯄꯣꯔꯠ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ꯫

꯱꯰꯰-ꯄꯣꯏꯟꯇ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯁ꯭ꯀꯣꯔꯀꯥꯔꯗ꯫

ꯀꯦꯇꯦꯒꯣꯔꯤ ꯈꯨꯗꯤꯡꯃꯛ ꯰ꯗꯒꯤ ꯵ ꯐꯥꯑꯣꯕꯥ ꯁ꯭ꯀꯣꯔ ꯇꯧ ꯑꯃꯁꯨꯡ ꯃꯁꯤꯒꯤ ꯑꯔꯨꯝꯕꯥ ꯑꯗꯨꯒꯥ ꯃꯁꯤꯡ ꯌꯥꯃꯍꯅꯒꯗꯕꯅꯤ꯫ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯔꯕꯥ ꯄ꯭ꯔꯃꯥꯅꯁꯤꯡ ꯑꯗꯨ ꯁ꯭ꯀꯣꯔ ꯈꯨꯗꯤꯡꯃꯛꯀꯤ ꯃꯅꯥꯛꯇꯥ ꯊꯝꯃꯨ꯫ ꯑꯄꯨꯅꯕꯥ ꯁ꯭ꯀꯣꯔ ꯑꯗꯨ ꯋꯥꯡꯂꯕꯥ ꯃꯇꯃꯗꯁꯨ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯒꯦꯇꯁꯤꯡ ꯄꯥꯁ ꯇꯧꯒꯗꯕꯅꯤ꯫

ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯑꯔꯨꯝꯕꯥ ꯀꯣꯔ ꯏꯚꯤꯗꯦꯟꯁ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯒꯦꯠ?
꯱.ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ., ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯁ꯭ꯇꯦꯇꯁ, ꯑꯃꯁꯨꯡ ꯑꯣꯗꯤꯠ ꯔꯦꯗꯤꯑꯣ꯫ ꯲꯰% ꯑꯃꯁꯨꯡ ꯑꯦꯟ. ꯂꯤꯒꯦꯜ ꯑꯥꯏꯗꯦꯟꯇꯤꯇꯤ, ꯁꯥꯏꯇꯁꯤꯡ, ISO 13485 ꯁ꯭ꯀꯣꯞ, QMSR/MDR ꯔꯦꯗꯤꯑꯣ, ꯄ꯭ꯔꯗꯛꯇ ꯑꯣꯊꯣꯔꯥꯏꯖꯦꯁꯟ꯫ ꯍꯣꯏ
ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ-ꯔꯦꯗꯤ ꯗꯣꯀꯨꯃꯦꯟꯇ ꯇꯧꯕꯥ꯫ ꯱꯵% ꯑꯃꯁꯨꯡ ꯑꯦꯟ. ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯗꯣꯁꯤꯌꯔ, ꯄ꯭ꯔꯗꯛꯇ ꯃꯥꯁ꯭ꯇꯔ ꯗꯦꯇꯥ, ꯂꯦꯕꯦꯂꯁꯤꯡ, ꯑꯥꯏ.ꯑꯦꯐ.ꯌꯨ.ꯁꯤꯡ, ꯇꯦꯁ꯭ꯇꯁꯤꯡ, ꯗꯤꯛꯂꯥꯔꯦꯁꯟ ꯑꯃꯁꯨꯡ ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ꯫ ꯍꯣꯏ
꯳.ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ, ꯌꯨ.ꯗꯤ.ꯑꯥꯏ., ꯑꯃꯁꯨꯡ ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯕꯥ꯫ ꯱꯵% ꯑꯃꯁꯨꯡ ꯑꯦꯟ. ꯂꯣꯠ ꯇ꯭ꯔꯦꯁ, UDI/ꯗꯤꯚꯥꯏꯁ ꯗꯦꯇꯥ, ꯀꯃꯞꯂꯦꯟꯇ ꯂꯤꯉ꯭ꯀꯦꯖ, ꯔꯤꯇꯦꯟꯁꯟ, ꯀꯁ꯭ꯇꯃꯔ ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯟ꯫ ꯍꯣꯏ
꯴.ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯣꯁꯦꯁ ꯚꯦꯂꯤꯗꯦꯁꯟ꯫ ꯱꯵% ꯑꯃꯁꯨꯡ ꯑꯦꯟ. ꯄ꯭ꯔꯣꯁꯦꯁ ꯐ꯭ꯂꯣ, ꯚꯦꯂꯤꯗꯦꯁꯟ, ꯀꯦꯂꯤꯕ꯭ꯔꯦꯁꯟ, ꯏꯟꯁꯄꯦꯛꯁꯟ, ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯁꯨꯡ ꯅꯟ-ꯀꯅꯐꯣꯔꯃꯦꯟꯁ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ꯫ ꯁ꯭ꯀꯣꯄꯀꯤꯗꯃꯛ ꯍꯣꯌ꯫
꯵.ꯗꯦꯂꯤꯕꯔꯤ, ꯏꯅꯚꯦꯟꯇꯔꯤ, ꯑꯃꯁꯨꯡ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ꯫ ꯱꯵% ꯑꯃꯁꯨꯡ ꯑꯦꯟ. ꯂꯤꯗ ꯇꯥꯏꯝ, ꯀꯦꯄꯥꯁꯤꯇꯤ, ꯁ꯭ꯇꯣꯛ, ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ., ꯑꯦꯁ꯭ꯀꯦꯂꯦꯁꯟ, ꯇ꯭ꯔꯥꯟꯁꯄꯣꯔꯠ ꯑꯃꯁꯨꯡ ꯀꯟꯇꯤꯟꯌꯨꯏꯇꯤꯒꯤ ꯏꯕꯤꯗꯦꯟꯁ꯫ ꯄꯟꯈꯩ
꯶.ꯑꯣ.ꯏ.ꯑꯦꯝ.ꯒꯤ ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯦꯝꯄꯜ ꯚꯦꯂꯤꯗꯦꯁꯟ꯫ ꯱꯰% ꯑꯃꯁꯨꯡ ꯑꯦꯟ. ꯗꯤꯖꯥꯏꯅꯒꯤ ꯊꯧꯗꯥꯡꯁꯤꯡ, ꯗ꯭ꯔꯣꯏꯪꯁꯤꯡ, ꯔꯤꯁ꯭ꯛ, ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ, ꯁꯦꯝꯄꯜ ꯑꯃꯁꯨꯡ ꯐꯥꯔꯁ꯭ꯠ-ꯂꯣꯠ ꯏꯕꯤꯗꯦꯟꯁ꯫ ꯄ꯭ꯔꯣꯖꯦꯛꯇꯀꯤ ꯃꯈꯥ ꯄꯣꯜꯂꯤ꯫
꯷.ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯄꯣꯁ꯭ꯠ-ꯃꯥꯔꯀꯦꯠ ꯁꯄꯣꯔꯠ꯫ ꯱꯰% ꯑꯃꯁꯨꯡ ꯑꯦꯟ. ꯇ꯭ꯔꯦ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ, ꯀꯝꯄꯦꯇꯤꯕꯤꯂꯤꯇꯤ, ꯇ꯭ꯔꯦꯅꯤꯡ, ꯀꯃꯞꯂꯦꯟꯇ, ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ., ꯔꯤꯄꯦꯌꯔ ꯑꯃꯁꯨꯡ ꯋꯥꯔꯦꯟꯇꯤ꯫ ꯄꯟꯈꯩ

ꯏꯚꯤꯗꯦꯟꯁ ꯁ꯭ꯀꯣꯔ ꯇꯧꯕꯒꯤ ꯁ꯭ꯀꯦꯜ꯫

ꯁ꯭ꯀꯣꯔ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯦꯚꯦꯜ ꯏꯟꯇꯔꯞꯔꯤꯇꯦꯁꯟ ꯇꯧꯕꯥ꯫
0 ꯄ꯭ꯔꯃꯥꯟ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ꯫ ꯃꯊꯧ ꯇꯥꯕꯥ ꯑꯗꯨ ꯌꯦꯡꯁꯤꯅꯕꯥ ꯉꯃꯗꯦ꯫
1 ꯋꯥꯍꯩꯅꯥ ꯀ꯭ꯂꯦꯝ ꯇꯧꯕꯥ ꯈꯛꯇꯃꯛ꯫ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯁꯄꯣꯔꯠ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯕꯥ ꯃꯥꯔꯀꯦꯇꯤꯡ ꯅꯠꯠꯔꯒꯥ ꯁꯦꯂꯁ ꯁ꯭ꯇꯦꯇꯃꯦꯟꯇ꯫
2 ꯃꯄꯨꯡ ꯐꯥꯗꯕꯥ ꯄ꯭ꯔꯃꯥꯟ꯫ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯁꯤꯡ ꯑꯁꯤ ꯃꯇꯝ ꯂꯣꯏꯔꯕꯥ, ꯂꯦꯞꯄꯥ ꯂꯩꯇꯕꯥ, ꯖꯦꯅꯦꯔꯦꯜ ꯑꯣꯏꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯃꯔꯨꯑꯣꯏꯕꯥ ꯁ꯭ꯀꯣꯞ ꯂꯩꯇꯕꯥ ꯑꯣꯏ꯫
3 ꯌꯥꯕꯥ ꯉꯝꯕꯥ ꯄ꯭ꯔꯃꯥꯟ꯫ ꯍꯧꯖꯤꯛ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯤꯕꯥ ꯔꯦꯀꯣꯔꯗꯁꯤꯡꯅꯥ ꯃꯊꯧ ꯇꯥꯕꯥ ꯑꯗꯨ ꯃꯔꯝ ꯆꯥꯅꯥ ꯎꯠꯂꯤ꯫
4 ꯑꯀꯅꯕꯥ ꯄ꯭ꯔꯃꯥꯟ ꯂꯩꯕꯥ꯫ ꯔꯦꯀꯣꯔꯗꯁꯤꯡꯗꯥ ꯍꯟꯗꯛꯀꯤ ꯈꯨꯗꯃꯁꯤꯡ, ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ, ꯃꯦꯠꯔꯤꯛ, ꯑꯃꯁꯨꯡ ꯗꯥꯌꯠꯕ ꯂꯩꯕꯥ ꯃꯄꯨꯁꯤꯡ ꯌꯥꯑꯣꯔꯤ꯫
5 ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯔꯕꯥ ꯄ꯭ꯔꯃꯥꯅꯁꯤꯡ꯫ ꯄ꯭ꯔꯃꯥꯟ ꯑꯁꯤ ꯄ꯭ꯔꯗꯛꯇ-ꯂꯤꯉ꯭ꯛ ꯇꯧꯕꯥ, ꯍꯟꯖꯤꯟ ꯍꯟꯖꯤꯟ ꯇꯧꯕꯥ ꯌꯥꯕꯥ, ꯌꯥꯔꯤꯕꯃꯈꯩ ꯃꯁꯥ ꯃꯊꯟꯇꯥ ꯀꯅꯐꯥꯔꯝ ꯇꯧꯕꯥ ꯑꯃꯁꯨꯡ ꯏꯐꯦꯛꯇꯤꯕ ꯀꯟꯠꯔꯣꯂꯁꯤꯡꯅꯥ ꯁꯄꯣꯔꯠ ꯇꯧꯕꯥ ꯌꯥꯏ꯫

ꯄ꯭ꯔꯦꯛꯇꯤꯀꯦꯜ ꯑꯦꯞꯔꯨꯕꯦꯜ ꯔꯨꯜ ꯑꯃꯅꯥ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯒꯦꯠ ꯄꯨꯝꯅꯃꯛ ꯄꯥꯁ ꯇꯧꯕꯥ, ꯔꯤꯖꯣꯂꯕ ꯇꯧꯗꯕꯥ ꯀ꯭ꯔꯤꯇꯤꯀꯦꯜ ꯐꯥꯏꯟꯗꯤꯡ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯕꯥ, ꯌꯥꯕꯥ ꯁꯦꯝꯄꯜ ꯅꯠꯠꯔꯒꯥ ꯑꯍꯥꯅꯕꯥ ꯂꯣꯠ ꯑꯃꯥ, ꯑꯃꯁꯨꯡ ꯀ꯭ꯔꯦꯇꯥ ꯑꯗꯨꯅꯥ ꯃꯃꯥꯡꯗꯥ ꯂꯦꯄꯊꯣꯀꯈꯤꯕꯥ ꯊ꯭ꯔꯦꯁꯍꯣꯜꯗ ꯑꯗꯨꯒꯤ ꯃꯊꯛꯇꯥ ꯋꯦꯏꯇꯦꯗ ꯁ꯭ꯀꯣꯔ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯕꯥ ꯌꯥꯏ꯫ ꯊ꯭ꯔꯦꯁꯍꯣꯜꯗ ꯑꯁꯤꯅꯥ ꯌꯨꯅꯤꯚꯔꯁꯦꯜ ꯅꯝꯕꯔ ꯑꯃꯒꯤ ꯃꯍꯨꯠꯇꯥ ꯗꯤꯚꯥꯏꯁ ꯔꯤꯁ꯭ꯛ ꯑꯃꯁꯨꯡ ꯕꯤꯖꯤꯅꯦꯁ ꯀ꯭ꯔꯤꯇꯤꯀꯦꯂꯤꯇꯤ ꯑꯗꯨ ꯔꯤꯐ꯭ꯂꯦꯛꯇ ꯇꯧꯒꯗꯕꯅꯤ꯫

ꯑꯣꯇꯣꯃꯦꯇꯤꯛ ꯗꯤꯁ꯭ꯀꯣꯂꯤꯐꯤꯀꯦꯁꯟ ꯅꯠꯠꯔꯒꯥ ꯑꯦꯁ꯭ꯀꯦꯂꯦꯁꯟ ꯔꯦꯗ ꯐ꯭ꯂꯦꯒꯁꯤꯡ꯫

ꯑꯥꯏꯅꯒꯤ ꯑꯣꯏꯕꯥ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ, ꯄ꯭ꯔꯗꯛꯁꯟ ꯁꯥꯏꯠ, ꯂꯦꯕꯦꯜ, ꯁꯔꯇꯤꯐꯤꯀꯦꯠ, ꯗꯤꯛꯂꯥꯔꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯀꯣꯇꯦꯁꯟ ꯑꯗꯨꯅꯥ ꯆꯞ ꯃꯥꯟꯅꯕꯥ ꯗꯥꯌꯠꯕ ꯂꯧꯔꯤꯕꯥ ꯑꯣꯔꯒꯥꯅꯥꯏꯖꯦꯁꯟ ꯑꯗꯨ ꯃꯁꯛ ꯈꯪꯗꯣꯀꯄꯥ ꯉꯃꯗꯦ꯫
'FDA ꯔꯦꯖꯤꯁ꯭ꯇꯔ ꯇꯧꯔꯕꯥ' ꯍꯥꯌꯕꯁꯤ ꯗꯤꯚꯥꯏꯁ ꯑꯃꯕꯨ FDAꯅꯥ ꯑꯌꯥꯕꯥ ꯄꯤꯔꯕꯥ, ꯀ꯭ꯂꯤꯌꯔ ꯇꯧꯔꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯑꯣꯊꯣꯔꯥꯏꯖ ꯇꯧꯔꯕꯥ ꯑꯣꯏ ꯍꯥꯌꯕꯒꯤ ꯄ꯭ꯔꯃꯥꯟ ꯑꯣꯏꯅꯥ ꯄꯤꯔꯤ꯫
ISO 13485 ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯑꯁꯤ ꯃꯇꯝ ꯂꯣꯏꯔꯕꯥ, ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯉꯃꯗꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯃꯔꯤ ꯂꯩꯅꯕꯥ ꯁꯥꯏꯠ ꯑꯃꯁꯨꯡ ꯊꯕꯛ ꯊꯧꯔꯃꯁꯤꯡ ꯀꯣꯅꯁꯤꯅꯗꯦ꯫
ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯅꯥ ꯄꯥꯟꯗꯝ ꯊꯝꯂꯤꯕꯥ ꯗꯦꯁ꯭ꯇꯤꯅꯦꯁꯟ ꯃꯥꯔꯀꯦꯠ ꯑꯗꯨꯒꯤꯗꯃꯛ ꯄ꯭ꯔꯗꯛꯇ-ꯁ꯭ꯄꯦꯁꯤꯐꯤꯛ ꯑꯣꯊꯣꯔꯥꯏꯖꯦꯁꯟ ꯎꯠꯄꯥ ꯌꯥꯔꯣꯏ꯫
ꯃꯦꯇꯔꯤꯑꯦꯜ, ꯗ꯭ꯔꯣꯏꯪ, ꯇꯦꯁ꯭ꯠ, ꯂꯦꯕꯦꯜ, ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯗꯛꯇ-ꯀꯣꯗ ꯔꯤꯚꯤꯖꯅꯁꯤꯡ ꯑꯁꯤ ꯗꯣꯁꯤꯌꯔ ꯄꯨꯝꯅꯃꯛꯇꯥ ꯈꯦꯠꯅꯩ꯫
ꯂꯣꯏꯁꯤꯜꯂꯕꯥ ꯂꯣꯠ ꯑꯃꯕꯨ ꯔꯣ ꯃꯦꯇꯔꯤꯌꯦꯜ, ꯄ꯭ꯔꯗꯛꯁꯟ, ꯏꯟꯁꯄꯦꯛꯁꯟ, ꯂꯦꯕꯦꯂꯤꯡ, ꯑꯃꯁꯨꯡ ꯔꯤꯂꯤꯖ ꯔꯦꯀꯣꯔꯗꯁꯤꯡꯗꯥ ꯇ꯭ꯔꯦꯁ ꯇꯧꯕꯥ ꯌꯥꯗꯦ꯫
ꯃꯔꯨꯑꯣꯏꯕꯥ ꯊꯧꯑꯣꯡꯁꯤꯡ ꯑꯁꯤ ꯀ꯭ꯕꯥꯂꯤꯐꯤꯀꯦꯁꯟ, ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇ, ꯃꯣꯅꯤꯇꯔꯤꯡ, ꯅꯠꯔꯒꯥ ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ ꯌꯥꯑꯣꯗꯅꯥ ꯑꯥꯎꯠꯁꯣꯔꯁ ꯇꯧꯏ꯫
ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯅꯥ ꯑꯏꯕꯥ ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯟ ꯌꯥꯎꯗꯅꯥ ꯃꯦꯇꯔꯤꯑꯦꯜ, ꯗꯤꯖꯥꯏꯟ, ꯄ꯭ꯔꯣꯁꯦꯁ, ꯂꯦꯕꯦꯂꯤꯡ, ꯄꯦꯀꯦꯖꯤꯡ, ꯅꯠꯠꯔꯒꯥ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯍꯣꯡꯗꯣꯀꯄꯥ ꯌꯥꯏ꯫
ꯑꯐꯕꯥ ꯄ꯭ꯔꯣꯇꯣꯇꯥꯏꯞ ꯑꯃꯥ ꯂꯩꯔꯤ, ꯑꯗꯨꯕꯨ ꯄꯨꯊꯣꯀꯄꯅꯥ ꯑꯌꯥꯕꯥ ꯄꯤꯔꯕꯥ ꯔꯤꯖꯜꯇ ꯑꯗꯨ ꯍꯟꯖꯤꯟ ꯍꯟꯖꯤꯟ ꯇꯧꯕꯥ ꯉꯃꯒꯅꯤ ꯍꯥꯌꯕꯒꯤ ꯄ꯭ꯔꯃꯥꯟ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ꯫
ꯀꯃꯞꯂꯦꯟꯇ, ꯑꯦꯗꯚꯥꯟꯁ-ꯏꯚꯦꯟꯇ, ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ., ꯐꯤꯜꯗ-ꯑꯦꯛꯁꯟ, ꯔꯤꯄꯦꯌꯔ, ꯑꯃꯁꯨꯡ ꯃꯍꯨꯠ ꯁꯤꯅꯕꯒꯤ ꯊꯧꯗꯥꯡꯁꯤꯡ ꯑꯁꯤ ꯗꯣꯀꯨꯃꯦꯟꯇ ꯂꯩꯇꯦ꯫

XC ꯃꯦꯗꯤꯀꯣꯗꯥ ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯆꯞ ꯃꯥꯟꯅꯕꯥ ꯐ꯭ꯔꯦꯃꯋꯥꯔꯛ ꯑꯁꯤ ꯑꯦꯞꯂꯥꯏ ꯇꯧꯒꯗꯒꯦ꯫

ꯑꯦꯛꯁ.ꯁꯤ.ꯃꯦꯗꯤꯀꯣ ꯌꯥꯑꯣꯅꯥ ꯀꯦꯟꯗꯤꯗꯦꯠ ꯈꯨꯗꯤꯡꯃꯛꯇꯥ ꯆꯞ ꯃꯥꯟꯅꯕꯥ ꯏꯕꯤꯗꯦꯟꯁꯇꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯕꯥ ꯁ꯭ꯀꯣꯔꯀꯥꯔꯗ ꯑꯗꯨ ꯑꯦꯞꯂꯥꯏ ꯇꯧꯒꯗꯕꯅꯤ꯫ ꯀ꯭ꯔꯦꯇꯥꯁꯤꯡꯅꯥ ꯃꯈꯥꯗꯥ ꯄꯤꯔꯤꯕꯥ ꯄꯕ꯭ꯂꯤꯛ ꯔꯤꯁꯣꯔꯁꯁꯤꯡ ꯑꯁꯤꯗꯒꯤ ꯍꯧꯕꯥ ꯌꯥꯏ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯅꯒꯤꯗꯃꯛꯇꯥ ꯄ꯭ꯔꯗꯛꯇ-, ꯃꯥꯔꯀꯦꯠ-, ꯑꯃꯁꯨꯡ ꯁꯥꯏꯠ-ꯁ꯭ꯄꯦꯁꯤꯐꯤꯛ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯅꯁꯤꯡ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯕꯥ ꯌꯥꯏ꯫

ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯀꯟꯠꯔꯣꯜ & ꯏꯟꯁꯄꯦꯛꯁꯟ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯁ꯭ꯇꯦꯖꯁꯤꯡ, ꯂꯦꯕꯣꯔꯦꯇꯔꯤꯒꯤ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤꯒꯤ ꯏꯅꯐꯣꯔꯃꯦꯁꯟ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ꯫ ꯏꯃꯞꯂꯥꯟꯇ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯃꯦꯆꯤꯅꯤꯡ, ꯃꯆꯥꯀꯁꯤꯡ, ꯑꯦꯗꯤꯇꯤꯕ ꯄꯨꯊꯣꯀꯄꯥ, ꯑꯃꯁꯨꯡ ꯁꯔꯐꯦꯁ-ꯇ꯭ꯔꯤꯠꯃꯦꯟꯇ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤꯁꯤꯡ ꯊꯤꯖꯤꯅꯕꯥ꯫ ꯑꯣ.ꯏ.ꯑꯦꯝ.&ꯑꯣ.ꯗꯤ.ꯑꯦꯝ.ꯒꯤ ꯁꯔꯕꯤꯁꯁꯤꯡ ꯀꯁ꯭ꯇꯝ ꯗꯤꯕꯦꯂꯄꯃꯦꯟꯇ, ꯁꯦꯝꯄꯜ, ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡ, ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯗꯛꯁꯟ ꯋꯥꯔꯀꯐ꯭ꯂꯣ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ꯫ ꯁꯞꯂꯥꯏ ꯆꯦꯟ & ꯋꯦꯌꯔꯍꯥꯎꯁꯤꯡ ꯁꯣꯔꯁꯤꯡ, ꯏꯅꯚꯦꯟꯇꯔꯤ, ꯗꯤꯁ꯭ꯄꯦꯆ, ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ, ꯑꯃꯁꯨꯡ ꯔꯤꯖꯅꯦꯜ ꯁꯄꯣꯔꯠ ꯏꯅꯐꯣꯔꯃꯦꯁꯟ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ꯫ ꯁꯦꯂꯁꯀꯤ ꯃꯇꯨꯡꯗꯥ ꯁꯄꯣꯔꯠ ꯀꯃꯞꯂꯦꯟꯇ ꯏꯅꯇꯦꯛ, ꯔꯤꯇꯔꯟ, ꯋꯥꯔꯦꯟꯇꯤ, ꯏꯅꯚꯦꯁ꯭ꯇꯤꯒꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯔꯤꯖꯣꯂꯨꯁꯅꯒꯤ ꯏꯅꯐꯣꯔꯃꯦꯁꯟ ꯔꯤꯚꯤꯌꯨ ꯇꯧ꯫ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯄ꯭ꯔꯗꯛꯇ ꯄꯣꯔꯇꯐꯣꯂꯤꯑꯣ ꯅꯣꯔꯃꯦꯜ ꯄ꯭ꯔꯗꯛꯇ ꯁ꯭ꯀꯣꯞ ꯑꯗꯨ ꯄ꯭ꯂꯥꯟ ꯇꯧꯔꯕꯥ ꯄꯔꯆꯦꯖ ꯑꯗꯨꯒꯥ ꯃꯥꯟꯅꯕ꯭ꯔꯥ ꯍꯥꯌꯕꯗꯨ ꯀꯅꯐꯥꯔꯝ ꯇꯧ꯫ ꯇ꯭ꯔꯥꯎꯃꯥ ꯁꯤꯁ꯭ꯇꯦꯝ ꯇ꯭ꯔꯥꯎꯃꯥ ꯏꯃꯞꯂꯥꯟꯇꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯣꯁꯤꯗ꯭ꯌꯨꯑꯣꯔꯒꯥ ꯃꯥꯟꯅꯕꯥ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ ꯕ꯭ꯔꯣꯎꯖ ꯇꯧꯕꯥ꯫ ꯁ꯭ꯄꯥꯏꯅꯦꯜ ꯁꯤꯁ꯭ꯇꯦꯝ ꯁ꯭ꯄꯥꯏꯅꯦꯜ ꯏꯃꯞꯂꯥꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯃꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯃꯔꯤ ꯂꯩꯅꯕꯥ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ ꯕ꯭ꯔꯣꯎꯖ ꯇꯧꯕꯥ꯫

ꯆꯥꯡ ꯅꯥꯏꯅꯥ ꯍꯪꯂꯀꯄꯥ ꯋꯥꯍꯪꯁꯤꯡ꯫

꯲꯰꯲꯶ꯇꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯏꯚꯥꯂꯨꯑꯦꯁꯅꯗꯥ ꯀꯔꯤ ꯑꯍꯣꯡꯕꯥ ꯂꯥꯀꯈꯤꯕꯒꯦ?

ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.ꯅꯥ ꯐꯦꯕ꯭ꯔꯨꯋꯥꯔꯤ ꯲, ꯲꯰꯲꯶ꯇꯥ ꯆꯠꯅꯕꯥ ꯍꯧꯈꯤ ꯑꯃꯁꯨꯡ ꯌꯨ.ꯑꯦꯁ.ꯀꯤ ꯑꯀꯛꯅꯕꯥ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯔꯤꯐꯔꯦꯟꯁ ꯇꯧꯗꯨꯅꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ. ꯑꯍꯥꯅꯕꯥ ꯏꯌꯨ.ꯗꯤ.ꯑꯦ.ꯑꯦꯝ.ꯏ.ꯗꯤ.ꯒꯤ ꯃꯣꯗ꯭ꯌꯨꯜ ꯃꯔꯤ ꯑꯁꯤ ꯲꯰꯲꯶ꯀꯤ ꯃꯦ ꯲꯸ꯗꯒꯤ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯑꯣꯏꯔꯀꯈꯤ, ꯍꯧꯖꯤꯛꯇꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯔꯤꯚꯤꯌꯨꯁꯤꯡꯅꯥ ꯏꯃꯞꯂꯤꯃꯦꯟꯇ ꯇꯧꯕꯒꯤ ꯄ꯭ꯔꯃꯥꯅꯁꯤꯡ ꯇꯦꯁ꯭ꯠ ꯇꯧꯒꯗꯕꯅꯤ, ꯀꯝꯄꯦꯅꯤ ꯑꯃꯗꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ. ꯅꯠꯔꯒꯥ ꯁꯤ.ꯏ.

ISO 13485 ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯑꯃꯥ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯅꯤ?

ꯂꯤꯒꯦꯜ ꯑꯣꯔꯒꯥꯅꯥꯏꯖꯦꯁꯅꯒꯤ ꯃꯃꯤꯡ, ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ-ꯁꯥꯏꯇꯀꯤ ꯑꯦꯗ꯭ꯔꯦꯁ, ꯁ꯭ꯀꯣꯞ, ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯅꯝꯕꯔ, ꯏꯁꯨ ꯇꯧꯔꯤꯕꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯟ ꯕꯣꯗꯤ, ꯑꯦꯛꯔꯦꯗꯤꯇꯦꯁꯟ, ꯍꯧꯖꯤꯛꯀꯤ ꯑꯣꯏꯕꯥ ꯁ꯭ꯇꯦꯇꯁ, ꯑꯃꯁꯨꯡ ꯃꯇꯝ ꯂꯣꯌꯔꯕꯥ ꯃꯇꯨꯡꯗꯥ ꯆꯦꯛ ꯇꯧ꯫ ꯑꯀꯨꯞꯄꯥ ꯃꯔꯣꯂꯁꯤꯡ ꯑꯗꯨ ꯇꯁꯦꯡꯕꯥ ꯄꯣꯠꯊꯣꯛ, ꯂꯦꯕꯦꯜ, ꯗꯤꯛꯂꯥꯔꯦꯁꯟ, ꯀꯣꯇꯦꯁꯟ, ꯑꯃꯁꯨꯡ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡꯒꯤ ꯊꯧꯗꯥꯡꯁꯤꯡꯒꯥ ꯆꯥꯡꯗꯝꯅꯕꯤꯌꯨ꯫

ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ ꯍꯥꯌꯕꯁꯤ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯗꯤꯚꯥꯏꯁ ꯑꯃꯥ ꯑꯦꯞꯔꯨꯕ ꯇꯧꯔꯦ ꯍꯥꯌꯕꯔꯥ?

ꯅꯠꯇꯦ, ꯑꯦꯐ.ꯗꯤ.ꯑꯦ. ꯑꯀꯛꯅꯕꯥ ꯗꯤꯚꯥꯏꯁ ꯀ꯭ꯂꯥꯁꯤꯐꯤꯀꯦꯁꯟ ꯑꯃꯁꯨꯡ ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯄꯥꯊ ꯑꯗꯨ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧ꯫

ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯅꯥ ꯀꯔꯤ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯁꯤꯡ ꯄꯤꯒꯗꯒꯦ?

ꯃꯊꯧ ꯇꯥꯕꯥ ꯄꯦꯀꯦꯖ ꯑꯁꯤ ꯄꯣꯠꯊꯣꯛ ꯑꯃꯁꯨꯡ ꯀꯩꯊꯦꯂꯒꯤ ꯃꯈꯥ ꯄꯣꯜꯂꯤ, ꯑꯗꯨꯕꯨ ꯃꯍꯧꯁꯥꯅꯥ ꯃꯁꯤꯗꯥ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯄꯣꯠꯊꯣꯛ ꯃꯥꯁ꯭ꯇꯔ ꯗꯦꯇꯥ, ꯃꯆꯥꯀꯁꯤꯡ, ꯗ꯭ꯔꯣꯏꯪꯁꯤꯡ, ꯂꯦꯕꯦꯂꯁꯤꯡ, ꯑꯥꯏ.ꯑꯦꯐ.ꯌꯨ.ꯁꯤꯡ, ꯔꯤꯁ꯭ꯛ ꯑꯃꯁꯨꯡ ꯇꯦꯁ꯭ꯠ ꯏꯕꯤꯗꯦꯟꯁ, ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯃꯐꯃꯗꯥ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯑꯃꯁꯨꯡ ꯄꯦꯀꯦꯖꯤꯡꯒꯤ ꯏꯅꯐꯣꯔꯃꯦꯁꯟ, ꯗꯤꯛꯂꯥꯔꯦꯁꯅꯁꯤꯡ, ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯄꯣꯠꯊꯣꯛ-ꯁ꯭ꯄꯦꯁꯤꯐꯤꯛ ꯑꯣꯊꯣꯔꯥꯏꯖꯦꯁꯟ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ ꯌꯥꯑꯣꯏ꯫

ꯃꯇꯝ ꯄꯨꯝꯅꯃꯛꯇꯥ ꯑꯣꯟ-ꯁꯥꯏꯠ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯣꯗꯤꯠ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯕꯔꯥ?

ꯅꯠꯇꯦ ꯑꯣꯗꯤꯠꯀꯤ ꯊꯣꯡ ꯑꯁꯤ ꯔꯤꯁ꯭ꯀꯇꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯒꯗꯕꯅꯤ꯫ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯔꯤꯚꯤꯌꯨ, ꯂꯥꯏꯕ ꯔꯤꯃꯣꯠ ꯑꯣꯗꯤꯠ, ꯁꯦꯝꯄꯜ ꯇꯦꯁ꯭ꯠ ꯇꯧꯕꯥ, ꯑꯃꯁꯨꯡ ꯊꯥꯔꯗ ꯄꯥꯔꯇꯤ ꯏꯚꯤꯗꯦꯟꯁ ꯑꯁꯤ ꯄꯔꯆꯦꯖ ꯈꯔꯒꯤꯗꯃꯛ ꯃꯇꯤꯛ ꯆꯥꯕꯥ ꯑꯣꯏꯕꯥ ꯌꯥꯏ꯫ ꯑꯅꯧꯕꯥ ꯏꯃꯞꯂꯥꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯃꯁꯤꯡ, ꯁ꯭ꯇꯦꯔꯤꯜ ꯗꯤꯚꯥꯏꯁꯁꯤꯡ, ꯃꯔꯨꯑꯣꯏꯕꯥ ꯑꯥꯎꯠꯁꯣꯔꯁ ꯇꯧꯔꯕꯥ ꯊꯧꯑꯣꯡꯁꯤꯡ, ꯍꯟꯖꯤꯟ ꯍꯟꯖꯤꯟ ꯀ꯭ꯕꯥꯂꯤꯇꯤꯒꯤ ꯋꯥꯐꯃꯁꯤꯡ, ꯅꯠꯠꯔꯒꯥ ꯁ꯭ꯠꯔꯦꯇꯦꯖꯤꯛ ꯑꯣ.ꯏ.ꯑꯦꯝ.

ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯗꯥ ꯀꯔꯝꯅꯥ ꯁ꯭ꯀꯣꯔ ꯇꯧꯒꯗꯒꯦ?

ꯄ꯭ꯔꯤꯗꯤꯐꯥꯏꯗ 0–5ꯒꯤ ꯏꯚꯤꯗꯦꯟꯁ ꯁ꯭ꯀꯣꯔꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯋꯦꯏꯇꯦꯗ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯁꯤꯖꯤꯟꯅꯧ꯫ ꯃꯃꯜ ꯅꯠꯠꯔꯒꯥ ꯗꯦꯂꯤꯚꯔꯤ ꯁ꯭ꯀꯣꯔꯁꯤꯡꯅꯥ ꯃꯥꯡꯈꯤꯕꯥ ꯀꯝꯞꯂꯥꯏꯑꯦꯟꯁ ꯑꯗꯨ ꯀꯝꯄꯦꯟꯁꯦꯁꯟ ꯇꯧꯕꯥ ꯉꯃꯗꯅꯕꯥ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ, ꯂꯤꯒꯦꯜ, ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ, ꯑꯃꯁꯨꯡ ꯇꯉꯥꯏꯐꯗꯕꯥ ꯀ꯭ꯕꯥꯂꯤꯇꯤꯒꯤ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯑꯗꯨ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯒꯦꯠ ꯑꯣꯏꯅꯥ ꯊꯝꯃꯨ꯫

ꯑꯦꯞꯔꯨꯚ ꯇꯧꯔꯕꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯕꯨ ꯀꯌꯥꯝ ꯀꯨꯏꯅꯥ ꯑꯃꯨꯛ ꯍꯟꯅꯥ ꯏꯚꯥꯜꯌꯨꯑꯦꯠ ꯇꯧꯒꯗꯒꯦ?

ꯗꯤꯚꯥꯏꯁ ꯑꯃꯁꯨꯡ ꯁꯞꯂꯥꯏ ꯔꯤꯁ꯭ꯀꯀꯤ ꯃꯇꯨꯡꯏꯟꯅꯥ ꯏꯟꯇꯔꯚꯦꯜ ꯑꯗꯨ ꯁꯦꯠ ꯇꯧ꯫ ꯑꯁꯣꯏ-ꯑꯉꯥꯝ ꯌꯥꯑꯣꯗꯕꯥ, ꯀꯃꯞꯂꯦꯟꯇ, ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ., ꯗꯦꯂꯤꯕꯔꯤ, ꯁꯔꯕꯤꯁ, ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯑꯃꯁꯨꯡ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯁ꯭ꯇꯦꯇꯁ, ꯑꯃꯁꯨꯡ ꯂꯦꯞꯇꯅꯥ ꯍꯣꯡꯂꯀꯄꯥ ꯌꯦꯡꯁꯤꯅꯕꯥ꯫ ꯑꯀꯅꯕꯥ ꯁꯃꯁ꯭ꯌꯥꯁꯤꯡ ꯅꯠꯠꯔꯒꯥ ꯑꯆꯧꯕꯥ ꯑꯍꯣꯡꯕꯁꯤꯡꯅꯥ ꯍꯥꯟꯅꯥ ꯔꯤꯚꯤꯌꯨ ꯑꯃꯥ ꯊꯣꯀꯍꯅꯒꯗꯕꯅꯤ꯫

ꯂꯣꯏꯁꯤꯟꯕ

ꯗꯤꯐꯦꯟꯁ ꯇꯧꯕꯥ ꯌꯥꯕꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯏꯚꯥꯂꯨꯑꯦꯁꯟ ꯑꯃꯅꯥ ꯃꯥꯔꯀꯦꯇꯤꯡ ꯀ꯭ꯂꯦꯃꯁꯤꯡꯕꯨ ꯇ꯭ꯔꯦꯁꯤꯕꯜ ꯏꯕꯤꯗꯦꯟꯁ ꯑꯣꯏꯅꯥ ꯑꯣꯟꯊꯣꯀꯏ꯫ ꯲꯰꯲꯶ꯇꯥ, ꯃꯗꯨꯗꯥ ꯌꯨ.ꯑꯦꯁ.-ꯃꯥꯔꯀꯦꯠ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.ꯒꯤ ꯏꯃꯞꯂꯤꯃꯦꯟꯇ ꯇꯧꯕꯥ ꯑꯃꯁꯨꯡ ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯏ.ꯌꯨ.ꯒꯤ ꯄꯣꯠꯊꯣꯀꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯏ.ꯌꯨ.ꯗꯤ.ꯑꯦ.ꯑꯦꯝ.ꯏ.ꯗꯤ. ꯀꯦꯟꯗꯤꯗꯦꯠ ꯈꯨꯗꯤꯡꯃꯛꯀꯤ ꯑꯣꯏꯅꯥ ꯆꯞ ꯃꯥꯟꯅꯕꯥ ꯁ꯭ꯀꯣꯔꯀꯥꯔꯗ ꯁꯤꯖꯤꯟꯅꯧ ꯑꯃꯁꯨꯡ ꯑꯦꯞꯔꯨꯚ ꯇꯧꯔꯕꯥ ꯃꯇꯨꯡꯗꯥ ꯄꯔꯐꯣꯃꯦꯟꯁ ꯑꯗꯨ ꯃꯈꯥ ꯇꯥꯅꯥ ꯃꯥꯄꯂꯅꯤ꯫

ꯑꯣꯊꯣꯔꯤꯇꯤ ꯑꯣꯏꯕꯥ ꯔꯤꯐꯔꯦꯟꯁꯁꯤꯡ꯫

  1. ꯌꯨ.ꯑꯦꯁ.ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.: ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯝ ꯔꯦꯒꯨꯂꯦꯁꯟ (ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.)꯫
  2. ꯌꯨ.ꯑꯦꯁ.ꯀꯤ ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.: ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.ꯅꯥ ꯆꯥꯡ ꯅꯥꯏꯅꯥ ꯍꯪꯂꯀꯄꯥ ꯋꯥꯍꯪꯁꯤꯡ꯫
  3. ꯌꯨ.ꯑꯦꯁ.ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.: ꯔꯦꯖꯤꯁ꯭ꯠꯔꯦꯁꯟ ꯚꯦꯔꯁꯦꯁ ꯗꯤꯚꯥꯏꯁ ꯑꯦꯞꯔꯨꯕꯦꯜ, ꯀ꯭ꯂꯤꯌꯔꯦꯟꯁ, ꯅꯠꯔꯒꯥ ꯑꯣꯊꯣꯔꯥꯏꯖꯦꯁꯟ꯫
  4. ꯌꯨꯔꯣꯄꯤꯌꯟ ꯀꯃꯤꯁꯟ: ꯲꯰꯲꯶ꯀꯤ ꯃꯦ ꯲꯸ꯗꯒꯤ ꯑꯍꯥꯅꯕꯥ ꯏ.ꯌꯨ.ꯗꯤ.ꯑꯦ.ꯑꯦꯝ.ꯏ.ꯗꯤ.ꯒꯤ ꯃꯣꯗ꯭ꯌꯨꯜ ꯃꯔꯤ ꯃꯦꯟꯗꯦꯇꯔꯤ ꯑꯣꯏꯒꯅꯤ꯫
  5. ꯏꯟꯇꯔꯅꯦꯁ꯭ꯅꯦꯜ ꯑꯣꯔꯒꯅꯥꯏꯖꯦꯁꯟ ꯐꯣꯔ ꯁ꯭ꯇꯦꯟꯗꯔꯗꯥꯏꯖꯦꯁꯟ: ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ ꯱꯳꯴꯸꯵—ꯃꯦꯗꯤꯀꯦꯜ ꯗꯤꯚꯥꯏꯁꯁꯤꯡꯒꯤ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯃꯁꯤꯡ꯫
ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯣꯛꯌꯨꯔꯃꯦꯟꯇ ꯗꯤꯁꯛꯂꯦꯃꯔ: ꯑꯥꯔꯇꯤꯀꯦꯜ ꯑꯁꯤꯅꯥ ꯖꯦꯅꯦꯔꯦꯜ ꯁꯞꯂꯥꯏꯌꯔ-ꯏꯚꯥꯜꯌꯨꯑꯦꯁꯟ ꯏꯅꯐꯣꯔꯃꯦꯁꯟ ꯄꯤꯔꯤ ꯑꯃꯁꯨꯡ ꯃꯁꯤ ꯂꯤꯒꯦꯜ, ꯔꯦꯒꯨꯂꯦꯇꯔꯤ, ꯀ꯭ꯂꯤꯅꯤꯀꯦꯜ, ꯅꯠꯠꯔꯒꯥ ꯀ꯭ꯕꯥꯂꯤꯇꯤ-ꯁꯤꯁ꯭ꯇꯦꯃꯒꯤ ꯄꯥꯎꯇꯥꯛ ꯅꯠꯇꯦ꯫ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯑꯁꯤ ꯗꯤꯚꯥꯏꯁ, ꯁꯤꯖꯤꯟꯅꯅꯕꯥ ꯄꯥꯟꯗꯝ ꯊꯝꯂꯤꯕꯥ, ꯀ꯭ꯂꯥꯁꯤꯐꯤꯀꯦꯁꯟ, ꯂꯩꯕꯥꯛ, ꯑꯃꯁꯨꯡ ꯁꯞꯂꯥꯏ-ꯆꯦꯅꯒꯤ ꯊꯧꯗꯥꯡꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯈꯦꯠꯅꯩ꯫ ꯀ꯭ꯕꯥꯂꯤꯐꯥꯏꯗ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ, ꯀ꯭ꯕꯥꯂꯤꯇꯤ, ꯇꯦꯛꯅꯤꯀꯦꯜ, ꯑꯃꯁꯨꯡ ꯀ꯭ꯂꯤꯅꯤꯀꯦꯜ ꯄꯔꯁꯣꯅꯦꯂꯁꯤꯡꯅꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯅꯠꯠꯔꯒꯥ ꯄ꯭ꯔꯗꯛꯇ ꯑꯦꯞꯔꯨꯚ ꯇꯧꯗ꯭ꯔꯤꯉꯩꯒꯤ ꯃꯃꯥꯡꯗꯥ ꯄ꯭ꯔꯃꯥꯅꯁꯤꯡ ꯑꯗꯨ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯒꯗꯕꯅꯤ꯫

ꯃꯔꯤ ꯂꯩꯅꯕꯥ ꯕ꯭ꯂꯣꯒꯁꯤꯡ꯫

ꯑꯩꯈꯣꯌꯒꯥ ꯄꯥꯎ ꯐꯥꯑꯣꯅꯕꯤꯌꯨ꯫

*ꯕꯤ꯲ꯕꯤ ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯣꯐꯦꯁ꯭ꯅꯦꯜ ꯏꯅꯛꯕꯥꯔꯤ ꯈꯛꯇꯃꯛ꯫ ꯑꯩꯈꯣꯌꯅꯥ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔꯁꯤꯡ, ꯏꯝꯄꯣꯔꯇꯔꯁꯤꯡ, ꯍꯣꯁ꯭ꯄꯤꯇꯥꯜ ꯄ꯭ꯔꯣꯛꯌꯨꯔꯃꯦꯟꯇ ꯇꯤꯃꯁꯤꯡ, ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯁꯔꯖꯔꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯍꯦꯜꯊꯀꯦꯌꯔ ꯄ꯭ꯔꯣꯐꯦꯁ꯭ꯅꯦꯂꯁꯤꯡꯕꯨ ꯃꯇꯦꯡ ꯄꯥꯡꯂꯤ꯫ ꯑꯩꯈꯣꯌꯅꯥ ꯃꯤꯑꯣꯏ ꯑꯃꯃꯃꯒꯤ ꯑꯅꯥꯕꯁꯤꯡꯗꯥ ꯍꯀꯊꯦꯡꯅꯅꯥ ꯌꯣꯜꯂꯤ꯫

*ꯆꯥꯅꯕꯤꯗꯨꯅꯥ jpg, png, pdf, dxf, dwg ꯐꯥꯏꯜ ꯈꯛꯇꯃꯛ ꯑꯄꯂꯣꯗ ꯇꯧꯕꯤꯌꯨ꯫ ꯁꯥꯏꯖ ꯂꯤꯃꯤꯠ ꯑꯁꯤ ꯲꯵ꯑꯦꯝ.ꯕꯤ.

ꯃꯥꯂꯦꯃꯒꯤ ꯑꯣꯏꯅꯥ ꯊꯥꯖꯕꯥ ꯌꯥꯕꯥ ꯑꯃꯥ ꯑꯣꯏꯅꯥ꯫ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇꯁꯤꯡ ꯁꯥꯕꯥ , ꯑꯦꯛꯁ.ꯁꯤ.ꯃꯦꯗꯤꯀꯣꯅꯥ ꯇ꯭ꯔꯣꯃꯥ, ꯁ꯭ꯄꯥꯏꯅꯦꯜ, ꯖꯣꯏꯟꯇ ꯔꯤꯀꯟꯁꯠꯔꯛꯁꯟ, ꯑꯃꯁꯨꯡ ꯁ꯭ꯄꯣꯔꯇꯁ ꯃꯦꯗꯤꯁꯤꯟ ꯏꯃꯞꯂꯥꯟꯇꯁꯤꯡ ꯌꯥꯑꯣꯅꯥ ꯑꯋꯥꯡꯕꯥ ꯊꯥꯛꯀꯤ ꯃꯦꯗꯤꯀꯦꯜ ꯁꯣꯂꯨꯁꯅꯁꯤꯡ ꯄꯤꯕꯗꯥ ꯑꯈꯟꯅꯕꯥ ꯃꯤꯠꯌꯦꯡ ꯆꯪꯂꯤ꯫ ꯆꯍꯤ ꯱꯹ ꯍꯦꯟꯅꯥ ꯑꯦꯛꯁꯄꯔꯠ ꯑꯣꯏꯕꯥ ꯑꯃꯁꯨꯡ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯅꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯑꯩꯈꯣꯌꯅꯥ ꯃꯥꯂꯦꯝ ꯁꯤꯅꯕꯥ ꯊꯨꯡꯅꯥ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯇꯔꯁꯤꯡ, ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯑꯣ.ꯏ.ꯑꯦꯝ./ꯑꯣ.ꯗꯤ.ꯑꯦꯝ.

ꯀꯨꯏꯛ ꯂꯤꯉ꯭ꯀꯁꯤꯡ꯫

ꯄꯥꯎ ꯐꯥꯎꯕ

ꯇꯤꯌꯥꯅꯟ ꯁꯥꯏꯕꯔ ꯁꯤꯇꯤ, ꯆꯥꯡꯎ ꯃꯤꯗꯜ ꯔꯣꯗ, ꯆꯥꯡꯓꯧ, ꯆꯥꯏꯅꯥ꯫
꯸꯶- 1731508910�

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