1 ꯆꯍꯤ ꯱꯴ꯒꯤ ꯄ꯭ꯔꯣꯐꯦꯁ꯭ꯅꯦꯜ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯗꯤꯚꯥꯏꯁ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯦꯂꯁ ꯑꯦꯛꯁꯄꯤꯔꯤꯑꯦꯟꯁ ꯂꯩꯕꯥ꯫

2 ISO 13485:2016 ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯟ / ꯁꯤ.ꯏ.

1 ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯀꯣꯄꯤꯁꯤꯡ ꯄꯤꯕꯥ꯫

꯲ ꯚꯤꯗꯤꯑꯣ ꯐꯦꯛꯇꯔꯤ ꯏꯟꯁꯄꯦꯛꯁꯅꯒꯤ ꯊꯧꯔꯥꯡ ꯇꯧꯕꯥ ꯌꯥꯏ꯫

ꯁ꯭ꯄꯥꯏꯅꯦꯜ ꯀꯣꯔꯗ, ꯏꯟꯠꯔꯥꯃꯦꯗꯨꯂꯦꯔꯤ ꯅꯦꯜ, ꯂꯣꯀꯤꯡ ꯄ꯭ꯂꯦꯠ, ꯀꯟꯚꯦꯟꯁꯅꯦꯜ ꯄ꯭ꯂꯦꯠ, ꯖꯣꯟ, ꯁ꯭ꯄꯣꯔꯇꯁ ꯃꯦꯗꯤꯁꯤꯟ, ꯑꯦꯛꯁꯇꯔꯅꯦꯜ ꯐꯤꯛꯁꯦꯁꯟ, ꯏꯂꯦꯛꯠꯔꯤꯛ ꯗ꯭ꯔꯥꯏꯂꯁꯤꯡ, ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡ꯫

꯱ ꯃꯔꯨꯑꯣꯏꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯑꯣꯇꯣꯃꯦꯁꯅꯒꯤ ꯆꯥꯡ ≥꯹꯵%

꯲ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ꯒꯤ ꯄ꯭ꯔꯗꯛꯁꯟ ꯀꯟꯠꯔꯣꯜ ꯄ꯭ꯔꯣꯁꯤꯖꯔꯁꯤꯡ ꯑꯀꯅꯕꯥ ꯃꯑꯣꯡꯗꯥ ꯏꯃꯞꯂꯤꯃꯦꯟꯇ ꯇꯧꯕꯥ꯫

꯳ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯔꯦꯀꯣꯔꯗ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ ꯃꯄꯨꯡ ꯐꯥꯅꯥ ꯄꯥꯡꯊꯣꯀꯄꯥ꯫

1 ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯄ꯭ꯔꯗꯛꯇꯁꯤꯡ: ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.꯱ ꯄꯤꯁ꯫

꯲ ꯀꯁ꯭ꯇꯝ ꯄ꯭ꯔꯗꯛꯇꯁꯤꯡ: ꯀꯦꯁ ꯑꯃꯗꯒꯤ ꯀꯦꯁ ꯑꯃꯗꯥ ꯏꯚꯥꯂꯨꯑꯦꯠ ꯇꯧꯕꯥ꯫

1 ꯆꯥꯡ ꯅꯥꯏꯅꯥ ꯑꯣꯔꯗꯔ ꯇꯧꯕꯥ: ꯊꯕꯛ ꯅꯨꯃꯤꯠ ꯷ꯅꯤꯒꯤ ꯃꯅꯨꯡꯗꯥ ꯊꯥꯕꯥ꯫

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

1 ꯏꯟꯇꯔꯅꯦꯁ꯭ꯅꯦꯜ ꯑꯦꯛꯁꯞꯔꯦꯁ (ꯗꯤ.ꯑꯩꯆ.ꯑꯦꯜ./ꯐꯦꯗꯑꯦꯛꯁ/ꯌꯨ.ꯄꯤ.ꯑꯦꯁ.): ꯅꯨꯃꯤꯠ ꯷-꯱꯵ꯅꯤ꯫

꯲ ꯑꯦꯌꯔ ꯐ꯭ꯔꯦꯠ: 0ꯅꯨꯃꯤꯠ ꯱ -꯲꯵ꯅꯤ꯫

1 ꯄ꯭ꯔꯣꯐꯦꯁ꯭ꯅꯦꯜ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ ꯇꯤꯃꯅꯥ ꯃꯄꯨꯡ ꯑꯣꯏꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯁꯄꯣꯔꯠ ꯄꯤꯔꯤ
2 ꯁꯥꯏꯟꯇꯤꯐꯤꯛ ꯁꯤꯄꯤꯡ ꯁꯣꯂꯨꯁꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯀꯁ꯭ꯇꯃꯁ ꯀ꯭ꯂꯤꯌꯔꯦꯟꯁꯀꯤ ꯃꯇꯦꯡ ꯄꯤꯔꯤ꯫

ꯑꯦꯛꯁꯞꯔꯦꯁ/ꯑꯦꯌꯔ ꯐ꯭ꯔꯦꯠ: ꯑꯣꯔꯗꯔ ꯑꯗꯨꯒꯤ ꯇꯁꯦꯡꯕꯥ ꯑꯔꯨꯝꯕꯥ ꯅꯠꯠꯔꯒꯥ ꯚꯣꯜꯌꯨꯃꯦꯠꯔꯤꯛ ꯑꯣꯏꯕꯥ ꯑꯔꯨꯝꯕꯥ ꯑꯗꯨꯅꯥ ꯆꯥꯔꯖ ꯇꯧꯏ꯫

1 ꯁꯤꯄꯃꯦꯟꯇ ꯇꯧꯗ꯭ꯔꯤꯉꯩꯒꯤ ꯃꯃꯥꯡꯗꯥ ꯄ꯭ꯔꯗꯛꯇꯀꯤ ꯐꯣꯇꯣꯁꯤꯡ ꯄꯤꯕꯥ꯫

2 ꯏꯟꯇꯔꯅꯦꯁ꯭ꯅꯦꯜ ꯇ꯭ꯔꯦꯀꯤꯡ ꯅꯝꯕꯔ ꯄꯤꯕꯥ (ꯔꯤꯑꯦꯜ-ꯇꯥꯏꯝ ꯇ꯭ꯔꯦꯀꯤꯡ ꯑꯁꯤ ꯑꯣꯟ... 

ꯀꯦꯇꯥꯂꯣꯒꯗꯒꯤ ꯄꯣꯠꯊꯣꯀꯁꯤꯡ ꯈꯅꯒꯠꯄꯥ -ꯁ꯭ꯄꯦꯁꯤꯐꯤꯀꯦꯁꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯃꯁꯤꯡ ꯀꯅꯐꯔꯝ ꯇꯧꯕꯥ --- ꯀꯟꯠꯔꯦꯛꯇ ꯁꯥꯏꯟ ꯇꯧꯕꯥ ꯑꯃꯁꯨꯡ ꯗꯤꯄꯣꯖꯤꯠ ꯄꯤꯕꯥ --- ꯄꯨꯊꯣꯀꯄꯥ/ꯁ꯭ꯇꯣꯛ ꯁꯦꯝ ꯁꯥꯕꯒꯤ ꯊꯧꯔꯥꯡ ꯇꯧꯕꯥ --- ꯕꯦꯂꯦꯟꯁ ꯄꯤꯕꯥ --- ꯄꯣꯠꯂꯃꯁꯤꯡ ꯊꯥꯗꯣꯀꯄꯥ ꯑꯃꯁꯨꯡ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁꯀꯤ ꯏꯅꯐꯣꯔꯃꯦꯁꯟ ꯄꯤꯕꯥ꯫

ꯇꯤ/ꯇꯤ (ꯋꯥꯏꯔ ꯇ꯭ꯔꯥꯟꯁꯐꯔ) ꯑꯃꯁꯨꯡ ꯑꯦꯟ.

ꯑꯦꯜ/ꯁꯤ (ꯂꯦꯇꯔ ꯑꯣꯐ ꯀ꯭ꯔꯦꯗꯤꯠ) ꯑꯃꯁꯨꯡ ꯑꯦꯟ.

ꯄꯦꯄꯔꯂꯦꯁꯇꯥ ꯂꯩꯕꯥ꯫

ꯑꯂꯤꯕꯥꯕꯥꯕꯥ ꯇ꯭ꯔꯦꯗ ꯑꯦꯁꯨꯔꯦꯟꯁ꯫

ꯑꯦꯛꯁ-ꯇ꯭ꯔꯥꯟꯁꯐꯔ ꯇꯧꯕꯥ꯫

ꯋꯦꯁ꯭ꯇꯔꯟ ꯌꯨꯅꯤꯌꯟꯗꯥ ꯂꯩꯕꯥ ꯌꯨ.ꯑꯦꯟ

ꯃꯅꯤꯒ꯭ꯔꯥꯝ꯫

1 ꯕꯦꯁꯤꯛ ꯁꯄꯣꯔꯠ: ꯑꯣꯄꯔꯦꯁꯟ ꯃꯦꯟꯌꯨꯑꯦꯂꯁꯤꯡ, ꯁꯔꯖꯤꯀꯦꯜ ꯚꯤꯗꯤꯑꯣꯁꯤꯡ꯫

2 ꯚꯦꯜꯌꯨ-ꯑꯦꯗꯦꯗ ꯁꯔꯚꯤꯁꯁꯤꯡ: ꯐꯦꯛꯇꯔꯤꯗꯥ ꯆꯠꯄꯥ, ꯀ꯭ꯂꯤꯅꯤꯀꯦꯜ ꯇꯦꯛꯅꯤꯀꯦꯜ ꯑꯦꯛꯁꯆꯦꯟꯖꯁꯤꯡ꯫

꯱ ꯄꯨꯡ ꯴꯸ꯒꯤ ꯃꯅꯨꯡꯗꯥ ꯄꯥꯎꯈꯨꯝ ꯄꯤꯕꯥ꯫

2 ꯇꯦꯛꯅꯤꯀꯦꯜ ꯁꯣꯂꯨꯁꯅꯁꯤꯡ ꯅꯠꯠꯔꯒꯥ ꯃꯍꯨꯠ ꯁꯤꯅꯕꯥ/ꯍꯜꯂꯀꯄꯒꯤ ꯁꯔꯚꯤꯁꯁꯤꯡ ꯄꯤꯕꯥ꯫

1 ꯄꯔꯆꯦꯖ ꯚꯣꯜꯌꯨꯃꯗꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯗꯨꯅꯥ ꯑꯦꯛꯁꯛꯂꯨꯁꯤꯕ/ꯅꯟ-ꯑꯦꯛꯁꯛꯂꯨꯁꯤꯕ ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯁꯅꯒꯤ ꯍꯀꯁꯤꯡ ꯄꯤꯕꯥ꯫

꯲ ꯆꯍꯤꯒꯤ ꯑꯣꯏꯅꯥ ꯌꯣꯅꯕꯥ ꯄꯥꯟꯗꯃꯁꯤꯡ ꯐꯪꯂꯕꯥ ꯃꯇꯨꯡꯗꯥ ꯇꯦꯔꯤꯇꯣꯔꯤꯒꯤ ꯍꯀꯁꯤꯡ ꯑꯄꯒ꯭ꯔꯦꯗ ꯇꯧꯕꯥ꯫

꯱ ꯑꯦꯟ.ꯗꯤ.ꯑꯦ.(ꯅꯟ-ꯗꯤꯁꯛꯂꯁꯔ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇ)ꯗꯥ ꯈꯨꯠꯌꯦꯛ ꯄꯤꯅꯈꯤꯕꯥ

2 ꯄꯣꯠꯊꯣꯛꯀꯤ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯀꯅꯐꯥꯔꯝ ꯇꯧꯕꯥ (ꯗ꯭ꯔꯣꯏꯪ/ꯀ꯭ꯂꯤꯅꯤꯀꯦꯂꯒꯤ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯀꯟꯕꯔꯁꯟ)

꯳ ꯗꯤꯖꯥꯏꯅꯒꯤ ꯁꯣꯂꯨꯁꯅꯁꯤꯡ ꯄꯤꯕꯥ꯫

꯴ ꯁꯦꯝꯄꯜ ꯀꯅꯐꯔꯝ ꯇꯧꯕꯥ꯫

꯵ ꯃꯁꯤꯡ ꯌꯥꯝꯅꯥ ꯄꯨꯊꯣꯀꯄꯥ꯫