ꯍ꯭ꯌꯥꯡꯖꯧ ꯁꯦꯖꯣꯌ ꯏꯂꯦꯛꯠꯔꯣꯅꯤꯛꯁ ꯑꯦꯟꯗ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇ ꯀꯣ ꯂꯤꯃꯤꯇꯦꯗꯅꯥ ꯄꯤꯈꯤ꯫
꯲꯰꯰꯲ꯗꯥ ꯂꯤꯡꯈꯠꯈꯤꯕꯥ ꯁꯦꯖꯣꯏ ꯑꯁꯤ ꯍꯣꯝ-ꯀꯦꯌꯔ ꯃꯦꯗꯤꯀꯦꯜ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ ꯗꯤꯖꯥꯏꯟ ꯇꯧꯕꯥ ꯑꯃꯁꯨꯡ ꯁꯥꯕꯗꯥ ꯃꯔꯨ ꯑꯣꯏꯕꯥ ꯃꯤꯠꯌꯦꯡ ꯊꯝꯕꯥ ꯌꯥꯝꯅꯥ ꯊꯨꯅꯥ ꯆꯥꯎꯈꯠꯂꯛꯂꯤꯕꯥ ꯍꯥꯏ-ꯇꯦꯛ ꯏꯂꯦꯛꯠꯔꯣꯅꯤꯛ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯑꯃꯅꯤ꯫ ꯑꯩꯈꯣꯌꯒꯤ ꯑꯅꯧꯕꯥ ꯑꯃꯁꯨꯡ ꯇꯦꯛꯅꯣꯂꯣꯖꯤꯒꯤ ꯑꯣꯏꯕꯥ ꯑꯦꯛꯁꯦꯂꯦꯟꯁ ꯑꯁꯤꯅꯥ ꯑꯋꯥꯡꯕꯥ ꯊꯥꯛꯀꯤ ꯗꯤꯚꯥꯏꯁꯁꯤꯡ ꯄꯨꯊꯣꯀꯄꯗꯥ ꯃꯇꯦꯡ ꯄꯥꯡꯂꯤ ꯍꯥꯌꯕꯗꯤ . ꯏꯂꯦꯛꯠꯔꯣꯅꯤꯛ ꯊꯥꯔꯃꯣꯃꯤꯇꯔꯁꯤꯡ , ꯏꯅꯐ꯭ꯔꯥꯔꯦꯗ ꯊꯥꯔꯃꯣꯃꯤꯇꯔꯁꯤꯡ, ꯕ꯭ꯂꯗ ꯒ꯭ꯂꯨꯀꯣꯖ ꯃꯣꯅꯤꯇꯔ ꯇꯧꯕꯒꯤ ꯁꯤꯁ꯭ꯇꯦꯃꯁꯤꯡ, ꯕ꯭ꯂꯗ ꯄ꯭ꯔꯦꯁꯔ ꯃꯣꯅꯤꯇꯔꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯑꯇꯣꯞꯄꯥ ꯀꯁ꯭ꯇꯃꯔꯁꯤꯡꯅꯥ ꯗꯤꯖꯥꯏꯟ ꯇꯧꯕꯥ ꯍꯣꯝ-ꯀꯦꯌꯔ ꯏꯛꯕꯤꯄꯃꯦꯟꯇꯁꯤꯡ꯫ ꯆꯥꯏꯅꯥꯗꯥ ꯍꯦꯜꯊ ꯀꯦꯌꯔꯒꯤ ꯄꯣꯠꯊꯣꯀꯁꯤꯡꯒꯤ ꯃꯔꯨꯑꯣꯏꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯥ ꯑꯣꯏꯅꯥ, ꯁꯦꯖꯣꯌꯅꯥ ꯃꯥꯂꯦꯝ ꯄꯨꯝꯕꯒꯤ ꯃꯁꯤꯒꯤ ꯀꯁ꯭ꯇꯃꯔꯁꯤꯡꯗꯥ ꯃꯒꯨꯟ ꯂꯩꯕꯥ, ꯑꯅꯧꯕꯥ ꯋꯥꯈꯜꯂꯣꯟ ꯑꯃꯁꯨꯡ ꯁꯔꯕꯤꯁ ꯄꯤꯕꯒꯤ ꯊꯥꯖꯕꯥ ꯌꯥꯕꯥ ꯃꯤꯡꯆꯠ ꯑꯃꯥ ꯁꯦꯃꯒꯠꯂꯦ꯫
ꯄꯣꯠꯊꯣꯛ ꯂꯥꯏꯟ ꯑꯁꯤ ꯃꯈꯥ ꯇꯥꯅꯥ ꯄꯥꯀꯊꯣꯛ ꯆꯥꯎꯊꯣꯛꯂꯀꯄꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯏꯂꯦꯛꯠꯔꯣꯅꯤꯛ ꯊꯥꯔꯃꯣꯃꯤꯇꯔ, ꯏꯂꯦꯛꯠꯔꯣꯅꯤꯛ ꯕ꯭ꯂꯗ ꯄ꯭ꯔꯦꯁꯔ ꯃꯣꯅꯤꯇꯔ, ꯏꯌꯥꯔ ꯊꯥꯔꯃꯣꯃꯤꯇꯔ, ꯑꯃꯁꯨꯡ ꯐꯣꯔꯍꯦꯗ ꯊꯥꯔꯃꯣꯃꯤꯇꯔꯁꯤꯡ ꯑꯁꯤ ꯌꯦꯡꯁꯤꯅꯕꯥ, ꯄꯨꯊꯣꯀꯄꯥ, ꯄꯨꯊꯣꯀꯄꯥ ꯑꯃꯁꯨꯡ ꯑꯣꯄꯔꯦꯠ ꯇꯧꯕꯥ ꯖꯌꯇꯦꯛ ꯍꯦꯜꯊꯀꯦꯌꯔ , ꯁꯦꯖꯣꯏꯒ꯭ꯔꯨꯄꯀꯤ ꯃꯈꯥꯗꯥ ꯂꯩꯕꯥ ꯀꯝꯄꯦꯅꯤ ꯑꯃꯅꯤ꯫
꯲꯰꯲꯳ꯗꯥ ꯍ꯭ꯌꯥꯡꯖꯧ ꯁꯦꯖꯣꯌ ꯏꯂꯦꯛꯠꯔꯣꯅꯤꯛꯁ ꯑꯦꯟꯗ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇ ꯀꯣ ꯂꯤꯃꯤꯇꯦꯗꯅꯥ ꯃꯁꯤꯒꯤ ꯃꯃꯤꯡ ꯑꯁꯤ ꯍꯣꯡꯗꯣꯀꯈꯤ ꯫ ꯁꯦꯖꯣꯌ ꯕꯥꯏꯑꯣꯃꯦꯗꯤꯀꯦꯜ ꯀꯣ., ꯂꯤꯃꯤꯇꯦꯗ ꯑꯃꯁꯨꯡ ꯃꯔꯨ ꯑꯣꯏꯅꯥ ꯀꯣꯚꯤꯗ-꯱꯹ ꯇꯦꯁ꯭ꯠ, ꯕ꯭ꯂꯗ ꯒ꯭ꯂꯨꯀꯣꯖ ꯃꯣꯅꯤꯇꯔ ꯇꯧꯕꯒꯤ ꯁꯤꯁ꯭ꯇꯦꯝ, ꯌꯨꯔꯤꯛ ꯑꯦꯁꯤꯗ ꯃꯣꯅꯤꯇꯔ ꯇꯧꯕꯒꯤ ꯁꯤꯁ꯭ꯇꯦꯝ, ꯍꯦꯃꯣꯒ꯭ꯂꯣꯕꯤꯟ ꯃꯣꯅꯤꯇꯔ ꯇꯧꯕꯒꯤ ꯁꯤꯁ꯭ꯇꯦꯝ, ꯅꯨꯄꯤ ꯍꯦꯜꯊꯀꯦꯌꯔ ꯇꯦꯁ꯭ꯇꯁꯤꯡꯒꯨꯝꯕꯥ ꯑꯋꯥꯡꯕꯥ ꯊꯥꯛꯀꯤ ꯈꯨꯠꯂꯥꯌꯁꯤꯡꯒꯥ ꯃꯔꯤ ꯂꯩꯅꯕꯥ ꯋꯥꯐꯃꯁꯤꯡ ꯊꯦꯡꯅꯔꯤ꯫
ꯁꯦꯖꯣꯏꯒ꯭ꯔꯨꯄꯀꯤ ꯄꯣꯠꯊꯣꯛ ꯄꯨꯝꯅꯃꯛ ꯑꯁꯤ ꯑꯩꯈꯣꯌꯒꯤ ꯏꯟꯇꯔꯅꯦꯜ ꯑꯥꯔ.ꯑꯦꯟꯗ.ꯗꯤ.ꯕꯤꯚꯥꯒꯅꯥ ꯗꯤꯖꯥꯏꯟ ꯇꯧꯈꯤ ꯑꯃꯁꯨꯡ ISO13485 ꯁ꯭ꯇꯦꯟꯗꯔꯗꯁꯤꯡꯒꯤ ꯃꯈꯥꯗꯥ ꯁꯥꯕꯅꯤ; ꯌꯨꯔꯣꯄꯤꯌꯟ ꯁꯤ.ꯏ. ꯑꯃꯁꯨꯡ ꯌꯨ.ꯑꯦꯁ.ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ ꯊꯦꯡꯅꯅꯕꯥ꯫
꯲꯰꯲꯴ ꯐꯥꯑꯣꯕꯗꯥ, ꯀꯟꯇꯦꯛꯇ ꯑꯃꯁꯨꯡ ꯅꯟ-ꯀꯟꯇꯦꯛꯇ ꯊꯥꯔꯃꯣꯃꯤꯇꯔ, ꯕ꯭ꯂꯗ ꯄ꯭ꯔꯦꯁꯔ ꯃꯣꯅꯤꯇꯔ, ꯑꯃꯁꯨꯡ ꯄꯂꯁ ꯑꯣꯛꯁꯤꯃꯤꯇꯔ ꯑꯅꯤꯃꯛ ꯌꯥꯑꯣꯅꯥ ꯖꯌꯇꯦꯀꯀꯤ ꯃꯦꯗꯤꯀꯦꯜ ꯗꯤꯚꯥꯏꯁꯁꯤꯡ ꯑꯁꯤ ꯁꯤ.ꯏ.ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.