ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡꯒꯤ ꯑꯣꯏꯅꯥ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯐꯕꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯑꯣ.ꯏ.ꯑꯦꯝ.

ꯄ꯭ꯔꯥꯏꯚꯦꯠ-ꯂꯦꯕꯦꯜ ꯅꯠꯠꯔꯒꯥ ꯍꯣꯏꯠ-ꯂꯦꯕꯦꯜ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯂꯥꯏꯅꯁꯤꯡ ꯏꯚꯥꯜꯌꯨꯑꯦꯠ ꯇꯧꯔꯤꯕꯥ ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯅꯥ ꯅꯍꯥꯛꯅꯥ ꯑꯣꯗꯤꯠ ꯔꯨꯝ ꯑꯃꯗꯥ ꯂꯧꯕꯥ ꯌꯥꯕꯥ ꯄ꯭ꯂꯦꯕꯨꯛ ꯑꯃꯥ ꯃꯊꯧ ꯇꯥꯏ꯫ ꯒꯥꯏꯗꯂꯥꯏꯟ ꯑꯁꯤꯅꯥ ꯲꯰꯲꯶ꯀꯤ ꯑꯣꯏꯅꯥ ꯃꯀꯣꯛ ꯊꯣꯡꯕꯥ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯑꯣ.ꯏ.ꯑꯦꯝ.ꯒꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯑꯁꯤ ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.

ꯅꯍꯥꯛꯅꯥ ꯇ꯭ꯔꯥꯟꯁꯄꯔꯦꯟꯇ ꯁ꯭ꯀꯣꯔꯤꯡ ꯃꯦꯊꯣꯗꯣꯂꯣꯖꯤ ꯑꯃꯥ, ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡꯁꯤꯡ, ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ ꯆꯦꯀꯂꯤꯁ꯭ꯇꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯅꯍꯥꯛꯀꯤ RFPꯗꯥ ꯀꯣꯄꯤ ꯇꯧꯕꯥ ꯌꯥꯕꯥ ꯁꯥꯏꯗ-ꯕꯥꯏ-ꯁꯥꯏꯗ ꯇꯦꯃꯞꯂꯦꯠ ꯑꯃꯥ ꯐꯪꯒꯅꯤ꯫ ꯄꯥꯟꯗꯝ: ꯁꯣꯔꯇꯂꯤꯁ꯭ꯇꯁꯤꯡ ꯌꯥꯡꯅꯥ ꯁꯦꯝꯕꯥ, ꯀ꯭ꯌꯨ.ꯑꯦ./ꯑꯥꯔ.ꯑꯦ.ꯒꯤ ꯔꯤꯚꯤꯌꯨꯁꯤꯡꯗꯥ ꯋꯥꯔꯦꯄꯁꯤꯡ ꯉꯥꯀꯊꯣꯀꯄꯥ, ꯑꯃꯁꯨꯡ ꯗꯥꯎꯅꯁ꯭ꯠꯔꯤꯝ ꯁꯔꯞꯔꯥꯏꯖꯁꯤꯡꯗꯒꯤ ꯂꯥꯞꯅꯥ ꯂꯩꯕꯥ꯫

ꯇꯔꯨ-ꯇꯅꯥꯅꯕꯥ ꯁꯤ.ꯇꯤ.ꯑꯦ.: ꯁꯤꯖꯤꯟꯅꯅꯕꯥ ꯁꯦꯝ-ꯁꯥꯕꯥ ꯁꯤꯠ ꯑꯃꯥ ꯄꯥꯝꯕꯤꯕ꯭ꯔꯥ? ꯃꯈꯥꯗꯥ ꯄꯤꯔꯤꯕꯥ ꯆꯥꯡꯗꯝꯅꯕꯥ ꯇꯦꯕꯜ ꯑꯁꯤ ꯅꯍꯥꯛꯀꯤ ꯁ꯭ꯞꯔꯦꯗꯁꯤꯠꯇꯥ ꯀꯣꯄꯤ ꯇꯧ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯕꯨ ꯔꯦꯉ꯭ꯛ ꯇꯧꯅꯕꯥ ꯃꯦꯊꯣꯗꯣꯂꯣꯖꯤ ꯁꯦꯛꯁꯅꯗꯒꯤ ꯁ꯭ꯀꯣꯔ ꯇꯧꯕꯒꯤ ꯑꯔꯨꯝꯕꯥ ꯍꯥꯄꯆꯤꯜꯂꯨ꯫

ꯃꯦꯊꯣꯗꯣꯂꯣꯖꯤ: ꯑꯩꯈꯣꯌꯅꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯗꯥ ꯀꯔꯝꯅꯥ ꯁ꯭ꯀꯣꯔ ꯇꯧꯈꯤꯕꯒꯦ꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯜ ꯁꯤꯁ꯭ꯇꯦꯃꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯔꯤꯁ꯭ꯛ ꯑꯃꯁꯨꯡ ꯚꯦꯜꯌꯨ ꯑꯗꯨ ꯐꯣꯡꯗꯣꯛꯅꯕꯥ ꯑꯩꯈꯣꯌꯅꯥ ꯗꯥꯏꯃꯦꯟꯁꯟ ꯷ ꯋꯥꯏꯇꯦꯞ ꯇꯧꯈꯤ꯫ ꯅꯍꯥꯛꯀꯤ ꯁꯣꯔꯇꯂꯤꯁ꯭ꯇꯀꯤꯗꯃꯛꯇꯥ ꯁ꯭ꯀꯣꯔꯀꯥꯔꯗ ꯑꯃꯥ ꯁꯦꯝꯅꯕꯥ ꯑꯔꯨꯝꯕꯥ ꯑꯁꯤ ꯁꯤꯖꯤꯟꯅꯧ꯫

• ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯔꯤꯒꯨꯂꯔ & ꯑꯣꯗꯤꯠ ꯔꯦꯗꯤꯑꯣ — ꯲꯲%

• ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ & ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯃꯦꯆ꯭ꯌꯨꯔꯤꯇꯤ — ꯱꯶%

• ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡꯒꯤ ꯑꯋꯥꯡꯕꯥ & ꯁ꯭ꯀꯦꯂꯦꯕꯤꯂꯤꯇꯤ — ꯱꯸%

• ꯊꯥꯖꯕꯥ ꯌꯥꯕꯥ & ꯈꯣꯡꯖꯦꯜ (ꯂꯤꯗ ꯇꯥꯏꯃꯁ/ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.ꯁꯤꯡ/ꯏꯅꯚꯦꯟꯇꯔꯤ) — ꯱꯸%

• ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡ ꯀꯣꯂꯥꯕꯣꯔꯦꯁꯟ & ꯀꯁ꯭ꯇꯃꯔꯥꯏꯖꯦꯁꯟ — ꯱꯰%

• ꯑꯄꯨꯅꯕꯥ ꯃꯃꯜ & ꯀꯝꯃꯔꯁꯤꯑꯦꯜ ꯇꯔꯃꯁꯤꯡ — ꯱꯰%

• ꯏꯚꯤꯗꯦꯟꯁ & ꯀꯁ꯭ꯇꯃꯔ ꯄ꯭ꯔꯨꯐ — ꯶%

ꯁ꯭ꯀꯣꯔꯤꯡ ꯔꯨꯕ꯭ꯔꯤꯛ (ꯀ꯭ꯕꯤꯛ ꯒꯥꯏꯗ): 0–2 (ꯃꯊꯧ ꯇꯥꯕꯥ), 3–4 (ꯏꯃꯔꯖꯤꯡ), 5–6 (ꯕꯦꯖ ꯂꯥꯏꯅꯒꯥ ꯃꯥꯟꯅꯩ), 7–8 (ꯃꯄꯥꯉ꯭ꯒꯜ ꯂꯩꯕꯥ), 9–10 (ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ)꯫ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯈꯨꯗꯤꯡꯃꯛ ꯑꯣꯖꯟ ꯄꯤꯌꯨ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯚꯦꯟꯗꯔꯁꯤꯡꯒꯤ ꯃꯔꯛꯇꯥ ꯆꯥꯡꯗꯝꯅꯕꯥ ꯌꯥꯕꯒꯤꯗꯃꯛ ꯋꯦꯏꯇꯦꯗ ꯇꯣꯇꯦꯜ ꯑꯃꯥ ꯂꯦꯄꯊꯣꯀꯎ꯫

ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯏꯅꯚꯦꯟꯇꯔꯤ ꯁ꯭ꯠꯔꯦꯇꯦꯖꯤꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯍꯦꯟꯅꯥ ꯀꯨꯞꯄꯥ ꯀꯟꯇꯦꯛꯁꯀꯤꯗꯃꯛꯇꯥ, ꯌꯦꯡꯕꯤꯌꯨ꯫ ꯐꯦꯛꯇꯔꯤꯒꯤ ꯇꯧꯕꯥ ꯉꯝꯕꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯈꯨꯠꯂꯥꯌꯁꯤꯡ ꯑꯃꯁꯨꯡ... ꯋꯦꯌꯔꯍꯥꯎꯁꯤꯡ & ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ ꯄ꯭ꯔꯦꯛꯇꯤꯁꯁꯤꯡꯒꯤ ꯄꯦꯖꯁꯤꯡ꯫

ꯃꯤꯠꯌꯦꯡ ꯑꯃꯗꯥ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯀꯟꯇꯦꯛꯁ (ꯌꯨ.ꯑꯦꯁ./ꯏ.ꯌꯨ./ꯑꯥꯔ.ꯑꯣ.ꯋꯥꯏ.)꯫

• ꯌꯨꯅꯥꯏꯇꯦꯗ ꯁ꯭ꯇꯦꯇꯁ (FDA QMSR): FDAꯅꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ. ꯑꯦꯐ.ꯗꯤ.ꯑꯦ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯝ ꯔꯦꯒꯨꯂꯦꯁꯟ ꯑꯦꯐ.ꯑꯦ.ꯀ꯭ꯌꯨ.ꯁꯤꯡꯗꯥ .

• ꯌꯨꯔꯣꯄꯤꯌꯟ ꯌꯨꯅꯤꯌꯟ (ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ. ꯲꯰꯱꯷/꯷꯴꯵): ꯅꯣꯇꯤꯐꯥꯏꯗ ꯕꯣꯗꯤꯁꯤꯡꯅꯥ ꯃꯔꯨꯑꯣꯏꯕꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯀꯟꯠꯔꯦꯛꯇ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔꯁꯤꯡꯗꯥ ꯑꯀꯅꯕꯥ ꯀꯟꯠꯔꯣꯜ ꯂꯩꯒꯅꯤ ꯍꯥꯌꯅꯥ ꯊꯥꯖꯩ, ꯃꯁꯤꯗꯥ ꯑꯌꯥꯝꯕꯅꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵/ꯑꯦꯝ.ꯗꯤ.ꯑꯦꯁ.ꯑꯦ.ꯄꯤ.ꯒꯤ ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯟ, ꯆꯦꯟꯖ-ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯟ ꯀ꯭ꯂꯣꯖꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯑꯣꯗꯤꯠꯀꯤ ꯍꯀꯁꯤꯡ ꯌꯥꯑꯣꯔꯤ꯫ ꯕꯤ.ꯑꯦꯁ.ꯑꯥꯏ.ꯅꯥ ꯃꯁꯤꯒꯤ ꯗꯣꯀꯨꯃꯦꯟꯇ ꯑꯦꯛꯁꯄꯦꯛꯇꯦꯁꯅꯁꯤꯡꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯁꯃꯖꯤꯟꯅꯔꯤ꯫ ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯕꯦꯁ꯭ꯠ-ꯄ꯭ꯔꯦꯛꯇꯤꯁ ꯒꯥꯏꯗꯂꯥꯏꯅꯁꯤꯡ꯫.

ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯟ ꯊꯦꯡꯊꯕꯥ ꯑꯃꯁꯨꯡ ꯏꯟꯁꯄꯦꯛꯁꯅꯒꯤ ꯐꯂꯁꯤꯡ ꯍꯟꯊꯍꯟꯅꯕꯥ ꯅꯍꯥꯛꯀꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇꯁꯤꯡ, ꯐꯥꯏꯂꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯃꯥꯅꯁꯤꯡ ꯑꯁꯤ ꯑꯦꯛꯁꯄꯦꯛꯇꯦꯁꯅꯁꯤꯡ ꯑꯁꯤꯒꯥ ꯃꯥꯟꯅꯅꯥ ꯊꯝꯃꯨ꯫

ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯑꯣ.ꯏ.ꯑꯦꯝ.ꯒꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯱꯰ (ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯅꯒꯤ ꯈꯣꯡꯊꯥꯡꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ)

꯱) ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯁ꯭ꯀꯣꯞ, ꯑꯣꯗꯤꯠ ꯍꯤꯁ꯭ꯇꯔꯤ, ꯑꯃꯁꯨꯡ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯁꯞꯂꯥꯏꯌꯔꯒꯤ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯁꯤꯁ꯭ꯇꯦꯝ ꯑꯁꯤ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ꯒꯥ ꯃꯥꯟꯅꯩ ꯍꯥꯌꯕꯥ ꯀꯅꯐꯔꯝ ꯇꯧꯕꯥ ꯑꯃꯁꯨꯡ ꯃꯁꯤꯒꯤ ꯲꯰꯲꯶ꯀꯤ ꯏꯅꯐꯣꯔꯁꯃꯦꯟꯇ ꯇꯥꯡ ꯐꯥꯑꯣꯕꯗꯥ ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯑꯀꯅꯕꯥ QMS ꯀꯅꯐꯣꯔꯃꯤꯇꯤꯅꯥ ꯄ꯭ꯔꯥꯏꯚꯦꯠ-ꯂꯦꯕꯦꯜ ꯄ꯭ꯔꯣꯒ꯭ꯔꯥꯃꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯑꯦꯛꯁꯄꯣꯖꯔ ꯍꯟꯊꯍꯜꯂꯤ ꯑꯃꯁꯨꯡ ꯅꯍꯥꯛꯀꯤ ꯅꯦꯇꯋꯥꯔꯛ ꯄꯨꯝꯅꯃꯛꯇꯥ ꯑꯣꯗꯤꯠꯀꯤ ꯄꯣꯠꯂꯨꯝ ꯍꯟꯊꯍꯜꯂꯤ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: ISO 13485 ꯁꯔꯇꯤꯐꯤꯀꯦꯠ (ꯏꯁꯨ ꯇꯧꯔꯤꯕꯥ, ꯅꯝꯕꯔ, ꯁ꯭ꯀꯣꯞ, ꯚꯦꯂꯤꯗꯤꯇꯤ), ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯅꯧꯕꯥ NB/MDSAP ꯑꯣꯗꯤꯠ ꯁꯣꯃꯥꯔꯤꯁꯤꯡ, CAPA ꯏꯐꯦꯛꯇꯤꯕꯅꯦꯁ ꯃꯦꯠꯔꯤꯀꯁꯤꯡ, ꯑꯃꯁꯨꯡ QMSR-ꯑꯦꯂꯥꯏꯟ ꯇꯧꯔꯕꯥ ꯐꯥꯏꯂꯁꯤꯡꯗꯥ ꯂꯦꯒꯦꯁꯤ QS ꯇꯔꯃꯁꯤꯡ (DMR/DHF/DHR) ꯃꯦꯄꯤꯡ ꯇꯧꯕꯥ ꯃꯦꯃꯣ ꯑꯃꯥ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯑꯄꯤꯀꯄꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯁ꯭ꯀꯣꯄꯁꯤꯡ (ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ, ꯗꯤꯁ꯭ꯠꯔꯤꯕ꯭ꯌꯨꯁꯟ ꯈꯛꯇꯃꯛ), ꯂꯦꯄꯈꯤꯕꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡ, ꯍꯟꯗꯛꯀꯤ ꯑꯣꯗꯤꯠꯁꯤꯡꯒꯤ ꯄ꯭ꯔꯨꯐ ꯂꯩꯇꯕꯥ, ꯅꯠꯠꯔꯒꯥ ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ.

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (ꯌꯨ.ꯑꯦꯁ./ꯏ.ꯌꯨ./ꯔꯣꯗ): ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.(ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ. ꯱꯳꯴꯸꯵ꯒꯥ ꯑꯦꯂꯥꯏꯟ ꯇꯧꯕꯥ); ꯏꯌꯨ ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯀꯟꯠꯔꯣꯜ ꯑꯦꯛꯁꯄꯦꯛꯇꯦꯁꯅꯁꯤꯡ꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯏꯃꯞꯂꯥꯟꯇ/ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡꯒꯤ ꯗꯤꯖꯥꯏꯟ/ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯑꯃꯁꯨꯡ CAPA ꯁ꯭ꯇꯦꯇꯁꯀꯥ ꯂꯣꯌꯅꯅꯥ ꯍꯧꯈꯤꯕꯥ ꯑꯣꯗꯤꯠ ꯑꯅꯤꯒꯤ ꯁꯃꯖꯤꯟꯅꯐꯝ ꯀꯣꯅꯁꯤꯜꯂꯤꯕꯥ ꯁ꯭ꯀꯣꯄꯀꯥ ꯂꯣꯌꯅꯅꯥ ꯅꯍꯥꯛꯀꯤ ISO 13485 ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯄꯤꯌꯨ꯫'

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯅꯕꯒꯤꯗꯃꯛ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯄꯤ.ꯗꯤ.ꯑꯦꯐ.; ꯔꯤꯗꯦꯛꯇ ꯇꯧꯔꯕꯥ ꯑꯣꯗꯤꯠ ꯔꯤꯄꯣꯔꯇꯁꯤꯡ꯫

ꯑꯣꯊꯣꯔꯤꯇꯤ ꯑꯣꯏꯕꯥ ꯔꯤꯐꯔꯦꯟꯁ: ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.ꯒꯤ ꯑꯣꯚꯔꯚꯤꯌꯨ ꯑꯃꯁꯨꯡ ꯇꯥꯏꯃꯂꯥꯏꯟ꯫.

꯲) ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.꯲꯰꯱꯷/꯷꯴꯵ ꯁꯞꯂꯥꯏꯌꯔ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯅꯣꯇꯤꯐꯥꯏꯗ ꯕꯣꯗꯤ ꯑꯦꯛꯁꯄꯦꯛꯇꯦꯁꯅꯁꯤꯡ (ꯏ.ꯌꯨ.-ꯕꯥꯎꯟꯗ ꯄ꯭ꯔꯣꯒ꯭ꯔꯥꯃꯁꯤꯡ)

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯃꯔꯨꯑꯣꯏꯕꯥ ꯁꯕꯀꯟꯠꯔꯦꯛꯇꯔꯁꯤꯡ/ꯀꯟꯠꯔꯦꯛꯇ ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯑꯣꯚꯔꯁꯥꯏꯠꯀꯤ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡ ꯃꯔꯝ ꯑꯗꯨꯅꯥ ꯅꯍꯥꯛꯀꯤ ꯁꯤ.ꯏ.

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯃꯔꯨꯑꯣꯏꯕꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯗꯥ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯕꯥ ꯉꯃꯗꯕꯥ ꯑꯁꯤ ꯄ꯭ꯔꯥꯏꯕꯦꯠ-ꯂꯦꯕꯦꯜ ꯂꯣꯟꯆ ꯇꯧꯕꯗꯥ ꯊꯤꯡꯕꯥ ꯉꯝꯕꯥ ꯀꯃꯟ ꯑꯣꯏꯕꯥ ꯑꯦꯟ.ꯕꯤ.

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯅꯤ: ꯀꯟꯠꯔꯦꯛꯇꯁꯤꯡꯅꯥ ꯂꯥꯎꯊꯣꯀꯈꯤꯗꯕꯥ ꯑꯣꯗꯤꯠꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯆꯦꯟꯖ ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯅꯁꯤꯡ ꯂꯦꯄꯊꯣꯀꯄꯥ ꯌꯥꯍꯜꯂꯤ; ꯃꯔꯨꯑꯣꯏꯕꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯅꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵/ꯑꯦꯝ.ꯗꯤ.ꯑꯦꯁ.ꯑꯦ.ꯄꯤ. ꯇꯦꯛꯅꯤꯀꯦꯜ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯅꯅꯥ ꯂꯥꯀꯄꯥ/ꯏꯅ-ꯄ꯭ꯔꯣꯁꯦꯁ/ꯐꯥꯏꯅꯦꯜ ꯏꯟꯁꯄꯦꯛꯁꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯑꯣꯚꯔꯁꯥꯏꯠꯁꯤꯡ ꯎꯠꯂꯤ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯑꯣꯗꯤꯠꯀꯤ ꯍꯛ ꯂꯩꯇꯦ; ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯕꯥ; ꯁꯀꯈꯉꯂꯕꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯂꯩꯇꯕꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (ꯌꯨ.ꯑꯦꯁ./ꯏ.ꯌꯨ./ꯑꯥꯔ.ꯑꯣ.): ꯏ.ꯌꯨ.ꯒꯤ ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.꯲꯰꯱꯷/꯷꯴꯵ ꯑꯦꯟ.ꯕꯤ.ꯒꯤ ꯗꯣꯀꯨꯃꯦꯟꯇꯁꯤꯡꯒꯤ ꯈꯨꯠꯊꯥꯡꯗꯥ ꯑꯦꯟꯁꯦꯛꯁ IX/XIꯒꯤ ꯒꯥꯏꯗꯂꯥꯏꯅꯁꯤꯡ; ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯂꯩ꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯍꯧꯖꯤꯛ ꯂꯩꯔꯤꯕꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯠꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯅꯍꯥꯛꯀꯤ ꯃꯔꯨꯑꯣꯏꯕꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡꯒꯤ ꯂꯤꯁ꯭ꯠ ꯑꯃꯥ ꯁꯦꯝꯃꯨ ꯑꯃꯁꯨꯡ ꯀꯟꯠꯔꯦꯛꯇꯀꯤ ꯑꯣꯗꯤꯠ/ꯆꯦꯟꯖ-ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯅꯒꯤ ꯍꯀꯁꯤꯡ ꯀꯅꯐꯥꯔꯝ ꯇꯧ꯫'

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯅꯕꯒꯤꯗꯃꯛ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯁꯔꯇꯤꯐꯥꯏ ꯇꯧꯔꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯂꯤꯁ꯭ꯠ; ꯁꯞꯂꯥꯏꯌꯔ ꯀꯟꯠꯔꯣꯂꯁꯤꯡꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯑꯦꯟ.ꯕꯤ.

ꯔꯤꯐꯔꯦꯟꯁ: ꯕꯤ.ꯑꯦꯁ.ꯑꯥꯏ.ꯒꯤ꯫ ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯗꯣꯀꯨꯃꯦꯟꯇꯦꯁꯅꯒꯤ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯐꯕꯥ ꯊꯧꯑꯣꯡꯁꯤꯡ꯫.

꯳) ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ ꯗꯦꯞꯊ (ꯔꯣ ꯃꯦꯇꯔꯤꯌꯦꯜ → ꯂꯣꯏꯁꯤꯜꯂꯕꯥ ꯂꯣꯠ), ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯁꯦꯝ ꯁꯥꯕꯥ, ꯑꯃꯁꯨꯡ ꯗꯤ.ꯑꯩꯆ.ꯑꯥꯔ

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯔꯣꯕꯁ꯭ꯠ DHRꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯀꯝꯞꯂꯥꯏꯑꯦꯟꯇ UDI ꯂꯦꯕꯦꯂꯤꯡ ꯑꯃꯁꯨꯡ ꯗꯦꯇꯥꯕꯦꯖ ꯁꯕꯃꯤꯁꯅꯁꯤꯡꯅꯥ ꯁꯄꯣꯔꯠ ꯇꯧꯕꯥ ꯑꯦꯟꯗ-ꯇꯨ-ꯑꯦꯟꯗ ꯕꯦꯆ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯍꯦꯟꯅꯥ ꯐꯕꯥ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤꯅꯥ ꯏꯅꯚꯦꯁ꯭ꯇꯤꯒꯦꯁꯅꯁꯤꯡ ꯈꯣꯡꯖꯦꯜ ꯌꯥꯡꯍꯜꯂꯤ, ꯔꯤꯀꯣꯜ ꯔꯦꯗꯤꯑꯣꯗꯥ ꯃꯇꯦꯡ ꯄꯥꯡꯏ ꯑꯃꯁꯨꯡ ꯍꯣꯁ꯭ꯄꯤꯇꯥꯜ ꯏꯅꯚꯦꯟꯇꯔꯤ ꯁꯤꯁ꯭ꯇꯦꯃꯁꯤꯡꯒꯥ ꯏꯟꯇꯤꯒ꯭ꯔꯦꯠ ꯇꯧꯏ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: DMR/DHF/DHRꯒꯤ ꯈꯨꯗꯃꯁꯤꯡ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ; ꯍꯤꯠꯁꯤꯡ/ꯂꯣꯠꯁꯤꯡꯗꯥ ꯔꯣ-ꯃꯦꯇꯔꯤꯌꯦꯜ ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ ꯀꯅꯐꯥꯔꯝ ꯇꯧꯕꯥ; UDI ꯂꯦꯕꯦꯂꯁꯤꯡ, ꯗꯥꯏꯔꯦꯛꯇ ꯄꯥꯔꯠ ꯃꯥꯔꯀꯤꯡ (ꯃꯊꯧ ꯇꯥꯕꯥ ꯃꯐꯃꯗꯥ), ꯑꯃꯁꯨꯡ ꯗꯦꯇꯥꯕꯦꯖ ꯑꯦꯟꯠꯔꯤꯁꯤꯡ (GUDID/Eudamed) ꯚꯦꯂꯤꯗꯦꯠ ꯇꯧꯕꯥ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯗꯤ.ꯑꯩꯆ.ꯑꯥꯔ.ꯒꯤ ꯒꯦꯄꯁꯤꯡ; ꯑꯦꯛꯁꯦꯞꯇꯦꯟꯁ/ꯂꯦꯕꯦꯜ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ ꯃꯥꯡꯈꯤꯕꯥ; ꯏꯅꯀꯣꯟꯁꯤꯁ꯭ꯇꯦꯟꯇ ꯑꯣꯏꯕꯥ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯗꯦꯇꯥ; ꯋꯥꯏꯛ ꯂꯦꯕꯦꯜ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯕꯥ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (ꯌꯨ.ꯑꯦꯁ./ꯏ.ꯌꯨ./ꯑꯥꯔ.ꯑꯣ.): ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ. ꯑꯃꯁꯨꯡ ꯖꯤ.ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯗꯤ.; ꯏ.ꯌꯨ.ꯒꯤ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ./ꯏꯎꯗꯥꯃꯦꯗ; QMSR/ISO 13485 ꯐꯥꯏꯜ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ ꯂꯩ꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'UDI ꯂꯦꯕꯦꯜ ꯄ꯭ꯔꯨꯐ, ꯑꯦꯛꯁꯦꯞꯇꯦꯟꯁ ꯔꯦꯀꯣꯔꯗꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯂꯣꯠꯇꯥ ꯇꯤꯡꯂꯕꯥ ꯔꯣ-ꯃꯦꯇꯔꯤꯌꯦꯜ ꯁꯤ.ꯑꯣ.ꯁꯤ.ꯁꯤꯡ ꯎꯠꯂꯤꯕꯥ ꯔꯤꯗꯦꯛꯇ ꯇꯧꯔꯕꯥ DHR ꯑꯃꯥ ꯄꯤꯌꯨ꯫'

ꯔꯤꯀꯣꯔꯗ ꯇꯧꯒꯗꯕꯥ ꯄ꯭ꯔꯃꯥꯟ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯗꯤ.ꯑꯩꯆ.ꯑꯥꯔ.ꯒꯤ ꯁꯦꯝꯄꯜ; UDI ꯁ꯭ꯛꯔꯤꯅꯁꯇꯁꯤꯡ (GUDID/Eudamed ꯑꯦꯟꯠꯔꯤꯁꯤꯡ)꯫

ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ ꯅꯣꯠ: ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯔ ꯑꯃꯅꯥ ꯑꯁꯤꯒꯨꯝꯕꯥ... ꯑꯦꯛꯁ.ꯁꯤ.ꯃꯦꯗꯤꯀꯣꯅꯥ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯂꯦꯖꯔ ꯃꯥꯔꯀꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯕꯦꯆ-ꯂꯦꯕꯦꯜ ꯇ꯭ꯔꯦꯀꯤꯡꯗꯥ ꯑꯀꯅꯕꯥ ꯋꯥꯐꯝ ꯊꯝꯂꯤ; ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯍꯦꯛꯇꯕꯨ ꯏꯚꯥꯜꯌꯨꯑꯦꯠ ꯇꯧꯕꯥ ꯃꯇꯃꯗꯥ, ꯃꯥꯔꯀꯤꯡ ꯑꯗꯨꯅꯥ DHR ꯂꯣꯇꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯗꯦꯇꯥꯕꯦꯖ ꯑꯦꯟꯠꯔꯤꯁꯤꯡꯗꯥ ꯀꯔꯝꯅꯥ ꯃꯦꯞ ꯇꯧꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯌꯦꯡꯅꯕꯥ ꯍꯥꯌꯌꯨ꯫

ꯑꯣꯊꯣꯔꯤꯇꯤ ꯑꯣꯏꯕꯥ ꯔꯤꯐꯔꯦꯟꯁꯁꯤꯡ: ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯁꯤꯁ꯭ꯇꯦꯝ ꯑꯣꯚꯔꯚꯤꯌꯨ ꯑꯃꯁꯨꯡ ꯏ.ꯌꯨ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯒꯥꯏꯗꯂꯥꯏꯅꯁꯤꯡ (ꯑꯦꯝ.ꯗꯤ.ꯁꯤ.ꯖꯤ.).

꯴) ꯄ꯭ꯔꯣꯁꯦꯁ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯃꯦꯆ꯭ꯌꯨꯔꯤꯇꯤ (ꯑꯥꯏ.ꯀ꯭ꯌꯨ./ꯑꯣ.ꯀ꯭ꯌꯨ./ꯄꯤ.ꯀ꯭ꯌꯨ.), ꯑꯦꯁ.ꯄꯤ.ꯁꯤ., ꯑꯃꯁꯨꯡ ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ꯫

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯁ꯭ꯇꯦꯇꯤꯁ꯭ꯇꯤꯀꯦꯜ ꯀꯟꯠꯔꯣꯜ ꯑꯃꯁꯨꯡ ꯗꯤꯁꯤꯞꯂꯤꯟ ꯌꯥꯑꯣꯕꯥ ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡ ꯆꯦꯟꯖ ꯃꯦꯅꯦꯖꯃꯦꯟꯇꯀꯥ ꯂꯣꯌꯅꯅꯥ ꯚꯦꯂꯤꯗꯦꯇꯦꯗ, ꯃꯣꯅꯤꯇꯔ ꯇꯧꯔꯕꯥ ꯄ꯭ꯔꯗꯛꯁꯟ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡ (ꯑꯥꯏ.ꯀ꯭ꯌꯨ./ꯑꯣ.ꯀ꯭ꯌꯨ./ꯄꯤ.ꯀ꯭ꯌꯨ.)꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯏꯃꯞꯂꯥꯟꯇꯁꯤꯡꯗꯥ ꯂꯦꯇꯦꯟꯇ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯑꯦꯁ꯭ꯀꯦꯄꯁꯤꯡ ꯍꯟꯊꯍꯜꯂꯤ ꯑꯃꯁꯨꯡ ꯑꯉꯀꯄꯥ ꯌꯥꯑꯣꯗꯅꯥ ꯂꯦꯞꯇꯅꯥ ꯔꯤꯞꯂꯦꯅꯤꯡ ꯇꯧꯕꯗꯥ ꯃꯇꯦꯡ ꯄꯥꯡꯏ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: ꯚꯦꯂꯤꯗꯦꯁꯟ ꯃꯥꯁ꯭ꯇꯔ ꯄ꯭ꯂꯥꯟ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯕꯥ; ꯃꯔꯨꯑꯣꯏꯕꯥ ꯊꯧꯑꯣꯡꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯑꯥꯏ.ꯀ꯭ꯌꯨ./ꯑꯣ.ꯀ꯭ꯌꯨ./ꯄꯤ.ꯀ꯭ꯌꯨ.ꯒꯤ ꯄꯦꯀꯦꯖꯁꯤꯡ (ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ, ꯁ꯭ꯇꯦꯔꯤꯜ ꯕꯦꯔꯤꯌꯥꯔ ꯁꯤꯂꯤꯡ, ꯀꯣꯇꯤꯡꯁꯤꯡ); ꯄ꯭ꯔꯗꯛꯁꯟ/ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯀꯤ ꯈꯨꯠꯂꯥꯌꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯁꯣꯐꯋꯦꯌꯔ ꯑꯦꯁꯨꯔꯦꯟꯁ; ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ/ꯚꯦꯂꯤꯗꯦꯁꯟ ꯑꯃꯁꯨꯡ ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯟ ꯇ꯭ꯔꯦꯂꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯆꯦꯟꯖ-ꯀꯟꯠꯔꯣꯜ ꯂꯣꯒꯁꯤꯡ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯃꯥꯡꯍꯟ ꯇꯥꯀꯍꯅꯕꯥ/ꯃꯄꯨꯡ ꯐꯥꯕꯥ ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ ꯇꯧꯕꯥ ꯉꯃꯗꯕꯥ ꯃꯐꯃꯗꯥ 'ꯇꯦꯁ꯭ꯠ‐ꯈꯛꯇꯒꯤ' ꯊꯥꯖꯕꯥ; ꯁꯣꯐꯇꯋꯥꯌꯔ ꯑꯦꯁꯨꯔꯦꯟꯁ ꯂꯩꯇꯕꯥ; ꯁ꯭ꯄꯣꯔꯦꯗꯤꯛ ꯆꯦꯟꯖ ꯂꯣꯒꯁꯤꯡ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (ꯌꯨ.ꯑꯦꯁ./ꯏ.ꯌꯨ./ꯑꯥꯔ.ꯑꯣ.ꯋꯥꯏ.): ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.ꯒꯤ ꯃꯈꯥꯗꯥ ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯄ꯭ꯔꯣꯁꯦꯁ ꯚꯦꯂꯤꯗꯦꯁꯅꯒꯤ ꯋꯥꯈꯜꯂꯣꯅꯁꯤꯡ; ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ ꯱꯳꯴꯸꯵ ꯷.꯵ ꯑꯃꯁꯨꯡ ꯑꯦꯟ. ꯔꯤꯁ꯭ꯀꯇꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯕꯥ ꯁꯣꯐꯇꯋꯥꯌꯔ ꯑꯦꯁꯨꯔꯦꯟꯁ꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯑꯈꯟꯅꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯑꯃꯒꯤꯗꯃꯛ ꯔꯤꯞꯔꯖꯦꯟꯇꯦꯇꯤꯚ IQ/OQ/PQ ꯑꯦꯛꯁꯔꯄꯁꯟ ꯑꯃꯥ ꯑꯃꯁꯨꯡ ꯆꯥꯡꯆꯠꯇꯥ ꯑꯣꯏꯕꯥ ꯁꯥꯏꯀꯜ ꯃꯇꯃꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯅꯍꯥꯛꯀꯤ ECN ꯋꯥꯔꯀꯐ꯭ꯂꯣ ꯑꯗꯨ ꯁꯦꯌꯔ ꯇꯧꯕꯤꯌꯨ꯫'

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯅꯕꯥ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯔꯤꯗꯦꯛꯇ ꯇꯧꯔꯕꯥ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯄꯦꯀꯦꯖꯁꯤꯡ; ꯏ.ꯁꯤ.ꯑꯦꯟ.ꯒꯤ ꯃꯦꯠꯔꯤꯀꯁꯤꯡ꯫

ꯔꯤꯐꯔꯦꯟꯁ: ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯑꯃꯁꯨꯡ ꯚꯦꯂꯤꯗꯦꯁꯅꯒꯤ ꯑꯣꯚꯔꯚꯤꯌꯨ꯫.

꯵) ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯤꯡ ꯗꯦꯞꯊ & ꯁ꯭ꯀꯦꯂꯦꯕꯜ ꯀꯦꯄꯥꯁꯤꯇꯤ (꯵-ꯑꯦꯛꯁꯤꯁ ꯁꯤ.ꯑꯦꯟ.ꯁꯤ., ꯐꯤꯅꯤꯁꯤꯡ, ꯀ꯭ꯂꯤꯅꯔꯨꯃꯁꯤꯡ, ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯃꯣꯗꯦꯜ)

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯏꯟ-ꯍꯥꯎꯁ ꯃꯦꯁꯤꯅꯤꯡ, ꯐꯤꯅꯤꯁꯤꯡ, ꯀ꯭ꯂꯤꯅꯔꯨꯝ ꯑꯣꯄꯔꯦꯁꯅꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯅꯒꯤ ꯑꯦꯞꯔꯣꯆ (ꯏꯟ-ꯍꯥꯎꯁ ꯕꯅꯥꯝ ꯀꯟꯠꯔꯦꯛꯇ)ꯒꯤ ꯄꯥꯛ-ꯆꯥꯎꯕꯥ ꯑꯃꯁꯨꯡ ꯀꯟꯠꯔꯣꯜ꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯍꯦꯟꯅꯥ ꯂꯨꯝꯅꯥ ꯂꯧꯕꯥ ꯏꯟ-ꯍꯥꯎꯁ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤꯅꯥ ꯍꯦꯟꯗꯑꯣꯐ ꯍꯟꯊꯍꯜꯂꯤ, ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯁ꯭ꯇꯦꯕꯤꯂꯥꯏꯖ ꯇꯧꯏ, ꯑꯃꯁꯨꯡ ꯑꯣ.ꯑꯥꯔ.-ꯀ꯭ꯔꯤꯇꯤꯀꯦꯜ ꯂꯥꯏꯅꯁꯤꯡꯒꯤ ꯂꯤꯗ ꯇꯥꯏꯝ ꯍꯟꯊꯍꯜꯂꯤ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: ꯐꯦꯁꯤꯂꯤꯇꯤ ꯇꯨꯔ ꯅꯠꯠꯔꯒꯥ ꯚꯤꯗꯤꯑꯣ; ꯇꯣꯂꯔꯦꯟꯁꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯏꯛꯕꯤꯄꯃꯦꯟꯇ ꯂꯤꯁ꯭ꯇꯁꯤꯡ; ꯀ꯭ꯂꯤꯅꯔꯨꯝ ꯀ꯭ꯂꯥꯁꯁꯤꯡ; ꯏꯟ-ꯍꯥꯎꯁ ꯕꯅꯥꯝ ꯑꯥꯎꯠꯁꯣꯔꯁ ꯇꯧꯔꯕꯥ ꯈꯣꯡꯊꯥꯡꯁꯤꯡ; ꯁꯦꯀꯦꯟꯗ-ꯁꯤꯐꯠ/ꯁꯔꯖ ꯔꯦꯗꯤꯑꯣ; ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯃꯣꯗꯦꯜ ꯑꯃꯁꯨꯡ ꯚꯦꯂꯤꯗꯦꯁꯅꯒꯤ ꯊꯧꯗꯥꯡꯁꯤꯡ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯀꯃꯞꯂꯦꯛꯁ ꯑꯥꯎꯠꯁꯣꯔꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯑꯄꯤꯀꯄꯥ ꯏꯟ-ꯍꯥꯎꯁ ꯁ꯭ꯇꯦꯄꯁꯤꯡ; ꯁꯔꯖ ꯄ꯭ꯂꯥꯟ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯅꯒꯤ ꯊꯧꯗꯥꯡꯁꯤꯡ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (ꯌꯨ.ꯑꯦꯁ./ꯏ.ꯌꯨ./ꯑꯥꯔ.ꯑꯣ.): ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ ꯱꯳꯴꯸꯵; ꯑꯦꯞꯂꯤꯀꯦꯕꯜ ꯑꯣꯏꯕꯥ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯁ꯭ꯇꯦꯟꯗꯔꯗꯁꯤꯡ (ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ, FDA ꯔꯤꯀꯣꯒꯅꯤꯁꯅꯒꯤ ꯈꯨꯠꯊꯥꯡꯗꯥ ISO 11135/11137/17665)꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯅꯍꯥꯛꯀꯤ ꯏꯛꯌꯨꯏꯄꯃꯦꯟꯇ ꯔꯣꯁ꯭ꯇꯔ (5-ꯑꯦꯛꯁꯤꯁꯀꯤ ꯑꯀꯨꯞꯄꯥ ꯃꯔꯣꯂꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ), ꯀ꯭ꯂꯤꯅꯔꯨꯝ ꯁ꯭ꯄꯦꯀꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯀꯔꯤ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡ ꯑꯁꯤ ꯑꯣꯟ-ꯁꯥꯏꯠ ꯕꯔꯁ ꯑꯥꯎꯠꯁꯣꯔꯁ ꯑꯣꯏꯅꯥ ꯚꯦꯂꯤꯗꯦꯠ ꯇꯧꯕꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯄꯤꯌꯨ꯫'

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯅꯕꯥ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯃꯦꯁꯤꯟ ꯂꯤꯁ꯭ꯠ; ꯀ꯭ꯂꯤꯅꯔꯨꯝ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯄꯤꯕꯥ; ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯑꯥꯎꯇꯂꯥꯏꯟ꯫

ꯈꯨꯗꯝ ꯑꯣꯏꯅꯥ ꯎꯠꯄꯥ ꯈꯨꯗꯝ: ꯑꯦꯛꯁ.ꯁꯤ.ꯃꯦꯗꯤꯀꯣꯅꯥ ꯑꯀꯅꯕꯥ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯔꯕꯥ ꯃꯦꯁꯤꯟ ꯑꯃꯁꯨꯡ ꯏꯟꯁꯄꯦꯛꯁꯟ ꯋꯥꯔꯀꯐ꯭ꯂꯣꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯇꯥꯏꯇꯅꯤꯌꯝ, ꯳꯱꯶ꯑꯦꯜ, ꯑꯃꯁꯨꯡ ꯃꯦꯗꯤꯀꯦꯜ-ꯒ꯭ꯔꯦꯗ ꯄꯤ.ꯏ.ꯏ.ꯀꯦ.ꯒꯤ ꯃꯔꯛꯇꯥ ꯊꯨꯄꯆꯤꯅꯕꯥ ꯎꯠꯂꯤ; ꯃꯥꯟꯅꯕꯥ ꯔꯤꯒꯨꯂꯔ ꯀꯅꯐꯥꯔꯝ ꯇꯧꯅꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯃꯒꯤ ꯐꯦꯛꯇꯔꯤ ꯇꯨꯔ ꯃꯦꯇꯔꯤꯑꯦꯂꯁꯤꯡ ꯅꯠꯠꯔꯒꯥ ꯏꯛꯌꯨꯏꯄꯃꯦꯟꯇ ꯂꯤꯁ꯭ꯠ ꯑꯗꯨ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ꯫

ꯁꯣꯐ꯭ꯠ ꯁꯤ.ꯇꯤ.ꯑꯦ.: ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤꯁꯤꯡ ꯊꯨꯅꯥ ꯆꯥꯡꯗꯝꯅꯕꯥ ꯄꯥꯝꯕꯤꯕꯔꯥ? ꯃꯈꯥꯗꯥ ꯄꯤꯔꯤꯕꯥ ꯇꯦꯕꯜ ꯑꯁꯤꯗꯥ ꯅꯍꯥꯛꯀꯤ ꯃꯀꯣꯛ ꯊꯣꯡꯕꯥ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯍꯨꯝ ꯑꯗꯨ ꯄꯦꯁ꯭ꯠ ꯇꯧꯕꯤꯌꯨ ꯑꯃꯁꯨꯡ ꯀꯅꯥꯅꯥ ꯂꯨꯆꯤꯡꯂꯤꯕꯅꯣ ꯍꯥꯌꯕꯗꯨ ꯌꯦꯡꯅꯕꯒꯤꯗꯃꯛ ꯃꯦꯊꯣꯗꯣꯂꯣꯖꯤ ꯁꯦꯛꯁꯅꯗꯒꯤ ꯑꯔꯨꯝꯕꯥ ꯑꯗꯨ ꯍꯥꯄꯆꯤꯜꯂꯨ꯫

꯶) ꯃꯦꯇꯔꯤꯑꯦꯂꯁꯤꯡ & ꯑꯈꯟꯅꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡꯒꯤ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤ (Ti‐6Al‐4V, 316L, PEEK; ꯀꯣꯇꯤꯡꯁꯤꯡ; ꯁꯔꯐꯦꯁ ​​ꯇ꯭ꯔꯤꯠꯃꯦꯟꯇꯁꯤꯡ)

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯕꯥꯏꯑꯣꯀꯝꯄꯤꯇꯤꯕꯤꯂꯤꯇꯤ ꯑꯃꯁꯨꯡ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯅꯒꯤ ꯑꯊꯤꯡꯕꯁꯤꯡꯒꯤ ꯃꯈꯥꯗꯥ ꯀꯃꯟ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯃꯦꯇꯔꯤꯑꯦꯂꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯚꯦꯂꯤꯗꯦꯠ ꯇꯧꯔꯕꯥ ꯑꯈꯟꯅꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡꯒꯤ ꯄ꯭ꯔꯃꯥꯟ ꯂꯩꯕꯥ ꯀꯟꯠꯔꯣꯜ꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨꯑꯣꯏꯕꯅꯣ: ꯃꯦꯇꯔꯤꯑꯦꯜ/ ꯄ꯭ꯔꯣꯁꯦꯁ ꯄꯦꯔꯤꯡꯅꯥ ꯁꯦꯐꯇꯤ, ꯄꯔꯐꯣꯃꯦꯟꯁ, ꯑꯃꯁꯨꯡ ꯂꯥꯏꯐꯁꯥꯏꯀꯂꯒꯤ ꯃꯃꯂꯗꯥ ꯍꯀꯊꯦꯡꯅꯅꯥ ꯁꯣꯀꯍꯜꯂꯤ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: ꯏꯅꯀꯝ ꯃꯦꯇꯔꯤꯑꯦꯜ ꯄꯦꯗꯤꯒ꯭ꯔꯤ (ꯁꯤ.ꯑꯣ.ꯁꯤ.ꯁꯤꯡ), ꯁ꯭ꯄꯦꯁꯤꯑꯦꯜ-ꯄ꯭ꯔꯣꯁꯦꯁ ꯚꯦꯂꯤꯗꯦꯁꯅꯁꯤꯡ, ꯔꯤꯞꯔꯖꯦꯟꯇꯦꯇꯤꯕ ꯗꯤꯚꯥꯏꯁꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯰꯹꯹꯳ ꯕꯥꯏꯑꯣꯀꯝꯄꯦꯇꯤꯕꯤꯂꯤꯇꯤ ꯏꯕꯤꯗꯦꯟꯁ, ꯑꯃꯁꯨꯡ ꯈꯅꯒꯠꯂꯕꯥ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯃꯣꯗꯦꯂꯤꯇꯤꯒꯥ ꯀꯝꯄꯦꯇꯤꯕꯤꯂꯤꯇꯤ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯁꯤ.ꯑꯣ.ꯁꯤ. ꯀꯣꯇꯤꯡꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯚꯦꯂꯤꯗꯦꯁꯅꯒꯤ ꯁꯃꯖꯤꯟꯅꯐꯝ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; ꯃꯌꯦꯛ ꯁꯦꯡꯗꯕꯥ ꯕꯥꯏꯑꯣꯀꯝꯄꯤꯇꯤꯕꯤꯂꯤꯇꯤ ꯔꯦꯁꯅꯑꯦꯜ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (ꯌꯨ.ꯑꯦꯁ./ꯏ.ꯌꯨ./ꯑꯥꯔ.ꯑꯣ.): ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯰꯹꯹꯳ ꯐꯦꯃꯤꯂꯤ; ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ ꯱꯹꯲꯲꯷ (ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯏꯃꯞꯂꯥꯟꯇꯁꯤꯡꯒꯤ ꯁꯦꯡꯗꯣꯀꯄꯥ); ꯃꯣꯗꯦꯂꯤꯇꯤꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯅꯒꯤ ꯁ꯭ꯇꯦꯟꯗꯔꯗꯁꯤꯡ꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯁꯦꯝꯄꯜ ꯁꯤ.ꯑꯣ.ꯁꯤ.ꯒꯤ ꯁꯦꯠ ꯑꯃꯥ ꯑꯃꯁꯨꯡ ꯅꯍꯥꯛꯀꯤ ꯏꯃꯞꯂꯥꯟꯇꯁꯤꯡꯗꯥ ꯁꯤꯖꯤꯟꯅꯔꯤꯕꯥ ꯀꯣꯇꯤꯡ/ꯁꯔꯐꯦꯁ ​​ꯇ꯭ꯔꯤꯠꯃꯦꯟꯇ ꯑꯃꯍꯦꯛꯇꯒꯤꯗꯃꯛ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯁꯣꯃꯥꯔꯤ ꯑꯃꯥ ꯁꯦꯌꯔ ꯇꯧꯕꯤꯌꯨ꯫'

ꯔꯤꯀꯣꯔꯗ ꯇꯧꯅꯕꯒꯤꯗꯃꯛ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯃꯦꯇꯔꯤꯑꯦꯜ ꯁꯤ.ꯑꯣ.ꯁꯤ.ꯁꯤꯡ; ꯀꯣꯇꯤꯡ ꯚꯦꯂꯤꯗꯦꯁꯅꯒꯤ ꯑꯦꯛꯁꯔꯄꯁꯟ꯫

ꯄ꯭ꯂꯦꯇꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯃꯦꯇꯔꯤꯑꯦꯂꯁꯤꯡ ꯍꯦꯟꯗꯜ ꯇꯧꯕꯗꯥ ꯑꯣꯄꯁꯅꯦꯜ ꯕꯦꯀꯒ꯭ꯔꯥꯎꯟꯗ ꯔꯤꯗꯤꯡ ꯇꯧꯕꯥ: ꯇꯥꯏꯇꯅꯤꯌꯝ ꯄ꯭ꯂꯦꯠ ꯁꯥꯕꯒꯤ ꯅꯣꯠꯁꯤꯡ꯫.

꯷) ꯊꯥꯖꯕꯥ ꯌꯥꯕꯥ & ꯈꯣꯡꯖꯦꯜ (ꯂꯤꯗ ꯇꯥꯏꯃꯁ, ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.ꯁꯤꯡ, ꯏꯅꯚꯦꯟꯇꯔꯤ ꯁ꯭ꯠꯔꯦꯇꯦꯖꯤ, ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.)

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯇ꯭ꯔꯥꯟꯁꯄꯔꯦꯟꯇ ꯂꯤꯗ ꯇꯥꯏꯃꯁꯤꯡ, ꯐ꯭ꯂꯦꯛꯁꯤꯕꯜ ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.ꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯑꯣꯟ-ꯇꯥꯏꯝ, ꯏꯟ-ꯐꯨꯜ (ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.) ꯗꯦꯂꯤꯕꯔꯤ ꯗꯤꯁꯤꯞꯂꯤꯅꯅꯥ ꯁꯄꯣꯔꯠ ꯇꯧꯕꯥ ꯄ꯭ꯔꯤꯗꯤꯛꯇꯦꯕꯜ ꯔꯤꯞꯂꯦꯅꯤꯡ꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯁ꯭ꯇꯦꯕꯜ ꯅꯠꯠꯔꯒꯥ ꯁꯦꯗ꯭ꯌꯨꯜ ꯑꯁꯤ ꯊꯥꯖꯕꯥ ꯌꯥꯕꯥ ꯏꯅꯚꯦꯟꯇꯔꯤꯒꯤ ꯃꯈꯥ ꯄꯣꯜꯂꯤ; ꯊꯥꯖꯕꯥ ꯌꯥꯕꯥ ꯑꯁꯤꯅꯥ ꯌꯥꯝꯅꯥ ꯊꯨꯅꯥ ꯃꯃꯜ ꯑꯃꯁꯨꯡ ꯀꯦꯟꯁꯦꯜ ꯇꯧꯕꯥ ꯍꯟꯊꯍꯜꯂꯤ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: ꯐꯣꯡꯈ꯭ꯔꯕꯥ ꯁ꯭ꯇꯣꯛ/ꯀꯁ꯭ꯇꯝ ꯂꯤꯗ ꯇꯥꯏꯃꯁꯤꯡ, ꯄꯨꯋꯥꯔꯤ ꯑꯣꯏꯔꯕꯥ ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.ꯀꯤ ꯇ꯭ꯔꯦꯟꯗꯁꯤꯡ, ꯏꯅꯚꯦꯟꯇꯔꯤ ꯄꯣꯂꯤꯁꯤ (ꯁꯦꯐꯇꯤ ꯁ꯭ꯇꯣꯛ, ꯀꯟꯁꯥꯏꯅꯃꯦꯟꯇ), ꯑꯃꯁꯨꯡ ꯂꯣꯖꯤꯁ꯭ꯇꯤꯛꯁ/ꯕ꯭ꯔꯣꯀꯦꯖ ꯄꯥꯔꯇꯅꯔꯁꯤꯡꯗꯥ ꯍꯪꯕꯤꯌꯨ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.ꯀꯤ ꯋꯥꯍꯟꯊꯣꯛ ꯅꯠꯔꯒꯥ ꯔꯤꯄꯣꯔꯠ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ; 'ꯃꯁꯤ ꯃꯈꯥ ꯄꯣꯜꯂꯤ' ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.ꯁꯤꯡꯗꯥ ꯄꯥꯎꯈꯨꯝ ꯄꯤꯔꯤ; ꯔꯨꯠ-ꯀꯣꯖ ꯑꯦꯅꯥꯂꯥꯏꯁꯤꯁ ꯌꯥꯑꯣꯗꯅꯥ ꯄꯥꯛ ꯁꯟꯅꯥ ​​ꯁꯣꯏ ꯇꯧꯕꯥ ꯂꯤꯗ ꯇꯥꯏꯃꯁꯤꯡ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (US/EU/RoW): ꯁ꯭ꯇꯦꯟꯗꯔꯗꯇꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯕꯥ ꯅꯠꯇꯦ, ꯑꯗꯨꯕꯨ ꯕꯦꯁ꯭ꯠ-ꯄ꯭ꯔꯦꯛꯇꯤꯁ ꯀꯦ.ꯄꯤ.ꯑꯥꯏ.ꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯑꯦꯁ.ꯑꯣ.ꯄꯤ.ꯁꯤꯡꯅꯥ ꯊꯥꯖꯕꯥ ꯌꯥꯕꯒꯤ ꯃꯈꯥ ꯄꯣꯜꯂꯤ꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯊꯥꯒꯤ ꯑꯣꯏꯅꯥ ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.ꯀꯤ ꯍꯧꯈꯤꯕꯥ ꯊꯥ ꯱꯲ ꯑꯃꯁꯨꯡ ꯄꯣꯠꯊꯣꯛ ꯐꯦꯃꯤꯂꯤꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯅꯍꯥꯛꯀꯤ ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯂꯤꯗ ꯇꯥꯏꯃꯁꯤꯡ ꯄꯤꯌꯨ (ꯁ꯭ꯇꯣꯛ ꯕꯅꯥꯝ ꯀꯁ꯭ꯇꯝ)꯫'

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯅꯕꯥ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ. ꯂꯤꯗ-ꯇꯥꯏꯝ ꯇꯦꯕꯂꯁꯤꯡ; ꯏꯅꯚꯦꯟꯇꯔꯤ ꯄꯣꯂꯤꯁꯤ꯫

ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.ꯀꯤ ꯋꯥꯍꯟꯊꯣꯀꯁꯤꯡꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯏꯟꯗꯁ꯭ꯠꯔꯤꯒꯤ ꯕꯦꯟꯆꯃꯥꯔꯛ ꯔꯤꯐꯔꯦꯟꯁ: ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.ꯇꯥ ꯃꯦꯀꯀꯤꯅꯁꯦꯒꯤ ꯑꯦꯛꯁꯞꯂꯦꯅꯔ꯫.

꯸) ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡ ꯀꯣꯂꯥꯕꯣꯔꯦꯁꯟ (ꯗꯤ.ꯑꯦꯐ.ꯑꯦꯝ./ꯗꯤ.ꯑꯦꯐ.ꯑꯦꯛꯁ., ꯁꯦꯝꯄꯂꯤꯡ ꯁ꯭ꯄꯤꯗ, ꯏ.ꯁꯤ.ꯑꯦꯟ.ꯒꯤ ꯔꯦꯁ꯭ꯄꯣꯟꯁꯤꯕꯤꯂꯤꯇꯤ, ꯗꯣꯀꯨꯃꯦꯟꯇꯦꯁꯟ ꯔꯤꯒꯨꯂꯔ)

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯁꯞꯂꯥꯏꯌꯔ ꯑꯗꯨꯅꯥ ꯗꯤꯖꯥꯏꯟ-ꯐꯣꯔ-ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔꯗꯥ ꯄꯥꯔꯇꯅꯔ ꯑꯣꯏꯕꯥ, ꯁꯦꯝꯄꯂꯁꯤꯡ ꯊꯨꯅꯥ ꯇꯨꯡꯁꯤꯅꯕꯥ, ꯑꯃꯁꯨꯡ ꯗꯤꯁꯤꯞꯂꯤꯟ ꯂꯩꯕꯥ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ/ꯆꯦꯟꯖ ꯀꯟꯠꯔꯣꯜ ꯆꯂꯥꯏꯕꯥ ꯉꯝꯕꯥ꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯑꯐꯕꯥ ꯄꯨꯟꯅꯥ ꯊꯕꯛ ꯇꯧꯃꯤꯟꯅꯕꯅꯥ ꯂꯥꯏꯐꯁꯥꯏꯀꯂꯒꯤ ꯃꯃꯜ ꯍꯟꯊꯍꯜꯂꯤ ꯑꯃꯁꯨꯡ ꯔꯦꯒꯨꯂꯦꯇꯔꯤ ꯔꯤꯚꯤꯌꯨ ꯇꯧꯕꯥ ꯃꯇꯃꯗꯥ ꯂꯦꯡꯗꯅꯥ ꯂꯩꯕꯥ ꯊꯤꯡꯏ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: ꯗꯤ.ꯑꯦꯐ.ꯑꯦꯝ./ꯗꯤ.ꯑꯦꯐ.ꯑꯦꯛꯁ. ꯁꯤ.ꯑꯦ.ꯗꯤ./ꯁꯤ.ꯑꯦ.ꯑꯦꯝ.ꯒꯤ ꯇꯨꯂꯆꯦꯅꯁꯤꯡ; ꯁꯦꯝꯄꯜ/ꯏ.ꯁꯤ.ꯑꯦꯟ.ꯒꯤ ꯇꯔꯅꯑꯣꯚꯔ ꯑꯦꯁ.ꯑꯦꯜ.ꯑꯦ.ꯁꯤꯡ; ꯂꯣꯜ/ꯇꯥꯏꯝ-ꯖꯣꯟ ꯀꯚꯔꯦꯖ; ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯕꯒꯤ ꯊꯧꯑꯣꯡꯁꯤꯡ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯁꯥꯡꯕꯥ, ꯚꯦꯔꯤꯑꯦꯕꯜ ꯁꯦꯝꯄꯜ ꯁꯥꯏꯀꯂꯁꯤꯡ; ꯑꯦꯗ-ꯍꯣꯛ ꯆꯦꯟꯖ ꯑꯦꯞꯔꯨꯕꯦꯂꯁꯤꯡ; ꯂꯤꯃꯤꯇꯦꯗ ꯏꯟꯖꯤꯅꯤꯌꯔꯤꯡ ꯕꯦꯟꯗꯋꯤꯊ ꯂꯩ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (US/EU/RoW): QMSR/ISO 13485 ꯗꯤꯖꯥꯏꯟ ꯑꯃꯁꯨꯡ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯀꯟꯠꯔꯣꯜ ꯀ꯭ꯂꯣꯖꯁꯤꯡ꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯗ꯭ꯔꯣꯏꯪ ꯑꯃꯁꯨꯡ ꯄ꯭ꯔꯣꯇꯣꯇꯥꯏꯄꯁꯤꯡꯒꯤ ꯃꯁꯛ ꯊꯣꯀꯄꯥ ꯇꯥꯏꯃꯂꯥꯏꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯍꯧꯈꯤꯕꯥ ꯆꯍꯤꯒꯤ ꯑꯣꯏꯅꯥ ꯏ.ꯁꯤ.ꯑꯦꯟ.ꯒꯤ ꯁꯥꯏꯀꯜ-ꯇꯥꯏꯝ ꯍꯤꯁ꯭ꯇꯣꯒ꯭ꯔꯥꯝ ꯑꯃꯥ ꯁꯦꯌꯔ ꯇꯧꯕꯤꯌꯨ꯫'

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯅꯕꯒꯤꯗꯃꯛ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯍꯟꯗꯛꯀꯤ ꯁꯦꯝꯄꯜ ꯁꯦꯗ꯭ꯌꯨꯜ; ꯏ.ꯁꯤ.ꯑꯦꯟ.ꯒꯤ ꯂꯣꯒ ꯑꯦꯛꯁꯦꯔꯄꯁꯅꯁꯤꯡ꯫

꯹) ꯁꯞꯂꯥꯏ ꯆꯦꯟ ꯔꯦꯁꯤꯂꯤꯌꯦꯟꯁ ꯑꯃꯁꯨꯡ ꯁꯦꯀꯦꯟꯗ-ꯁꯣꯔꯁ ꯀꯟꯇꯤꯟꯌꯨꯏꯇꯤ ꯄ꯭ꯂꯥꯅꯤꯡ꯫

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯗ꯭ꯌꯨꯑꯦꯜ-ꯁꯣꯔꯁꯤꯡ, ꯁꯦꯐꯇꯤ ꯁ꯭ꯇꯣꯛ, ꯑꯃꯁꯨꯡ ꯁꯔꯖ ꯄ꯭ꯂꯥꯅꯁꯤꯡꯒꯤ ꯈꯨꯠꯊꯥꯡꯗꯥ ꯁꯣꯀꯍꯜꯂꯀꯄꯥ ꯍꯟꯊꯍꯟꯅꯕꯥ ꯁ꯭ꯠꯔꯀꯆꯔꯦꯜ ꯔꯤꯁ꯭ꯛ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯀꯟꯇꯤꯟꯌꯨꯏꯇꯤꯅꯥ ꯀꯦꯟꯁꯦꯜ ꯇꯧꯔꯕꯥ ꯄ꯭ꯔꯣꯁꯤꯗ꯭ꯌꯨꯔꯁꯤꯡ ꯊꯤꯡꯏ ꯑꯃꯁꯨꯡ ꯔꯦꯚꯤꯟꯌꯨ ꯉꯥꯀꯊꯣꯀꯏ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: ꯁꯞꯂꯥꯏꯌꯔ ꯔꯤꯁ꯭ꯛ ꯇꯌꯥꯔꯁꯤꯡ; ꯁꯦꯀꯦꯟꯗ-ꯁꯣꯔꯁ ꯑꯦꯔꯦꯟꯖꯃꯦꯟꯇꯁꯤꯡ; ꯕꯤꯖꯤꯅꯦꯁ ꯀꯟꯇꯤꯟꯌꯨꯏꯇꯤ/ꯗꯤꯖꯥꯁ꯭ꯇꯔ ꯔꯤꯀꯣꯚꯔꯤ ꯇꯦꯁ꯭ꯠ ꯇꯧꯕꯥ; ꯀꯟꯁꯥꯏꯅꯃꯦꯟꯇ ꯑꯣꯄꯁꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯕ꯭ꯁ꯭ꯇꯤꯆ꯭ꯌꯨꯁꯟ ꯄꯣꯂꯤꯁꯤꯁꯤꯡ ꯌꯥꯑꯣꯔꯤ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯀꯟꯇꯤꯟꯖꯦꯟꯁꯤ ꯌꯥꯑꯣꯗꯅꯥ ꯁꯤꯉ꯭ꯒꯜ-ꯁꯥꯏꯠ ꯗꯤꯄꯦꯟꯗꯦꯟꯁ; ꯑꯣꯄꯦꯛ ꯁꯕꯀꯟꯠꯔꯦꯛꯇꯔꯁꯤꯡ; ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯇꯦꯁ꯭ꯠ ꯇꯧꯕꯥ ꯂꯩꯇꯦ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (US/EU/RoW): ISO 14971 ꯄ꯭ꯔꯤꯟꯁꯤꯄꯂꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ QMSR/ISO 13485ꯒꯤ ꯃꯈꯥꯗꯥ ꯔꯤꯁ꯭ꯀꯇꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯕꯥ ꯄꯔꯆꯦꯖ ꯇꯧꯕꯥ꯫

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯃꯊꯛꯀꯤ ꯏꯃꯞꯂꯥꯟꯇ ꯏꯃꯨꯡꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯅꯍꯥꯛꯀꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯔꯤꯁ꯭ꯛ ꯔꯦꯖꯤꯁ꯭ꯇꯔ ꯑꯃꯁꯨꯡ ꯗꯣꯛꯌꯨꯃꯦꯟꯇ ꯇꯧꯔꯕꯥ ꯀꯟꯇꯤꯟꯌꯨꯏꯇꯤ ꯄ꯭ꯂꯥꯅꯁꯤꯡ ꯄꯤꯌꯨ꯫'

ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯅꯕꯒꯤꯗꯃꯛ ꯏꯚꯤꯗꯦꯟꯁ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯔꯤꯁ꯭ꯛ ꯔꯦꯖꯤꯁ꯭ꯇꯔꯒꯤ ꯑꯦꯛꯁꯔꯁꯥꯏꯖ; ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯇꯦꯁ꯭ꯠ ꯔꯤꯄꯣꯔꯠ ꯇꯧꯕꯥ꯫

꯱꯰) ꯑꯄꯨꯅꯕꯥ ꯃꯃꯜ, ꯀꯝꯃꯔꯁꯤꯑꯦꯜ ꯇꯔꯃꯁꯤꯡ, ꯑꯥꯏ.ꯄꯤ./ꯇꯨꯂꯤꯡ ꯑꯣꯅꯔꯁꯤꯞ, ꯑꯃꯁꯨꯡ ꯁꯔꯕꯤꯁ ꯑꯦꯁ.ꯑꯦꯜ.ꯑꯦ

ꯃꯁꯤ ꯀꯔꯤꯅꯣ: ꯃꯃꯜ ꯂꯦꯞꯄꯒꯤ ꯃꯣꯗꯦꯂꯁꯤꯡ, ꯄꯦꯃꯦꯟꯇ ꯇꯔꯃꯁꯤꯡ, ꯑꯥꯏ.ꯄꯤ./ꯇꯨꯂꯤꯡ ꯑꯣꯅꯔꯁꯤꯞ, ꯑꯃꯁꯨꯡ ꯃꯔꯤ ꯑꯁꯤꯕꯨ ꯁꯦꯃꯗꯣꯛ-ꯁꯦꯃꯖꯤꯟ ꯇꯧꯔꯤꯕꯥ ꯁꯔꯚꯤꯁꯀꯤ ꯊꯥꯀꯁꯤꯡꯒꯤ ꯃꯌꯦꯛ ꯁꯦꯡꯕꯥ꯫

ꯍꯣꯁ꯭ꯄꯤꯇꯥꯂꯁꯤꯡ/ꯑꯥꯏ.ꯗꯤ.ꯑꯦꯟ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯀꯔꯤꯒꯤꯗꯃꯛꯇꯥ ꯃꯔꯨ ꯑꯣꯏꯔꯤꯕꯅꯣ: ꯇ꯭ꯔꯥꯟꯁꯄꯔꯦꯟꯇ ꯇꯔꯃꯁꯤꯡꯅꯥ ꯃꯄꯨ ꯑꯣꯏꯕꯒꯤ ꯑꯄꯨꯅꯕꯥ ꯃꯃꯜ ꯍꯟꯊꯍꯜꯂꯤ ꯑꯃꯁꯨꯡ ꯋꯥꯊꯣꯀꯁꯤꯡ ꯊꯤꯡꯏ꯫

ꯃꯇꯧ ꯀꯔꯝꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯒꯗꯒꯦ: ꯚꯣꯜꯌꯨꯝ ꯕ꯭ꯔꯦꯀꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯇꯔꯝ ꯁꯤꯠꯁꯤꯡ; ꯄꯦꯃꯦꯟꯇꯀꯤ ꯇꯔꯃꯁꯤꯡ; ꯋꯥꯔꯦꯟꯇꯤ/ꯔꯤꯇꯔꯅꯁꯤꯡ; ꯇꯨꯂꯤꯡ ꯑꯃꯁꯨꯡ ꯗꯤꯖꯥꯏꯟ ꯐꯥꯏꯂꯁꯤꯡꯒꯤ ꯃꯌꯦꯛ ꯁꯦꯡꯕꯥ ꯃꯄꯨ ꯑꯣꯏꯕꯥ; ꯄ꯭ꯔꯥꯏꯚꯦꯠ-ꯂꯦꯕꯦꯂꯗꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯕꯥ ꯒꯣꯄꯟ ꯑꯣꯏꯕꯥ/IP ꯀ꯭ꯂꯣꯖꯁꯤꯡ꯫

ꯂꯥꯂꯍꯧꯒꯤ ꯐꯤꯔꯥꯂꯁꯤꯡ: ꯑꯔꯥꯅꯕꯥ ꯑꯥꯏ.ꯄꯤ.ꯒꯤ ꯀ꯭ꯂꯣꯖꯁꯤꯡ; ꯇꯨꯂꯤꯡ ꯑꯣꯅꯔꯁꯤꯞ ꯍꯣꯡꯗꯣꯀꯄꯥ; ꯄꯅꯤꯇꯤꯕ ꯆꯦꯟꯖꯒꯤ ꯐꯤꯁꯤꯡ꯫

ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯃꯦꯄꯤꯡ (US/EU/RoW): ꯀꯟꯠꯔꯦꯛꯇꯀꯤ ꯑꯥꯏꯟ ꯑꯁꯤ ꯇꯣꯉꯥꯟ-ꯇꯣꯉꯥꯅꯕꯥ ꯑꯣꯏ; ꯏꯟꯇꯔꯅꯦꯜ ꯂꯤꯒꯦꯜ ꯑꯃꯁꯨꯡ ꯖꯤ.ꯄꯤ.ꯑꯣ.

ꯁꯦꯝꯄꯜ RFP/RFQ ꯋꯥꯍꯪꯁꯤꯡ: 'ꯇꯨꯂꯤꯡ ꯑꯣꯅꯔꯁꯤꯞ, ꯗꯤꯖꯥꯏꯟ ꯐꯥꯏꯜ ꯑꯦꯛꯁꯦꯁ, ꯑꯃꯁꯨꯡ ꯆꯦꯟꯖ-ꯅꯣꯇꯤꯐꯤꯀꯦꯁꯅꯒꯤ ꯃꯇꯃꯁꯤꯡ ꯎꯠꯂꯤꯕꯥ ꯗ꯭ꯔꯥꯐ MSA/ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇ ꯑꯃꯥ ꯑꯦꯇꯦꯆ ꯇꯧꯕꯤꯌꯨ꯫'

ꯔꯤꯀꯣꯔꯗ ꯇꯧꯒꯗꯕꯥ ꯄ꯭ꯔꯃꯥꯟ ꯂꯤꯉ꯭ꯀꯁꯤꯡ: ꯗ꯭ꯔꯥꯐ ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯦ.; ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇ; ꯋꯥꯔꯦꯟꯇꯤ ꯄꯣꯂꯤꯁꯤ꯫

ꯁꯞꯂꯥꯏꯌꯔ ꯆꯥꯡꯗꯝꯅꯕꯥ ꯇꯦꯕꯜ ꯇꯦꯃꯞꯂꯦꯠ (ꯀꯣꯄꯤ-ꯔꯦꯗꯤ)

ꯇꯦꯕꯜ ꯑꯁꯤ ꯅꯍꯥꯛꯀꯤ ꯁ꯭ꯞꯔꯦꯗꯁꯤꯠꯇꯥ ꯀꯣꯄꯤ ꯇꯧ ꯑꯃꯁꯨꯡ ꯃꯦꯊꯣꯗꯣꯂꯣꯖꯤꯒꯤ ꯑꯔꯨꯝꯕꯥ ꯑꯗꯨꯗꯥ ꯌꯨꯝꯐꯝ ꯑꯣꯏꯗꯨꯅꯥ ꯁ꯭ꯀꯣꯔ ꯇꯧꯕꯥ ꯀꯣꯂꯃꯁꯤꯡ ꯍꯥꯄꯆꯤꯜꯂꯨ꯫

ꯁꯞꯂꯥꯏꯌꯔ ꯑꯣꯏꯕꯥ꯫	ꯁꯔꯇꯤꯐꯤꯀꯦꯁꯅꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯁ꯭ꯀꯣꯞ꯫	ꯚꯦꯂꯤꯗꯦꯇꯦꯗ ꯄ꯭ꯔꯣꯁꯦꯁꯁꯤꯡ (ꯑꯥꯏ.ꯀ꯭ꯌꯨ./ꯑꯣ.ꯀ꯭ꯌꯨ./ꯄꯤ.ꯀ꯭ꯌꯨ.)	ꯂꯤꯗ ꯇꯥꯏꯝ (ꯁ꯭ꯇꯣꯛ/ꯀꯁ꯭ꯇꯝ)	ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.ꯁꯤꯡ꯫	ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤꯒꯤ ꯁ꯭ꯀꯣꯞ꯫	ꯃꯦꯇꯔꯤꯑꯦꯂꯁꯤꯡꯒꯤ ꯀꯦꯄꯦꯕꯤꯂꯤꯇꯤ (Ti‐6Al‐4V/316L/PEEK)	ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯅꯒꯤ ꯊꯧꯗꯥꯡ ꯂꯧꯕꯥ꯫	ꯅꯣꯇꯁꯤꯡ꯫

ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ ꯆꯦꯀꯂꯤꯁ꯭ꯠ (ꯅꯍꯥꯛꯀꯤ RFPꯗꯥ ꯑꯦꯇꯦꯆ ꯇꯧꯕꯤꯌꯨ)

• ꯀ꯭ꯕꯥꯂꯤꯇꯤ & ꯔꯦꯒꯨꯂꯦꯇꯔꯤ: ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ (ꯏꯁꯨ ꯇꯧꯔꯤꯕꯥ/ꯅꯝꯕꯔ/ꯁ꯭ꯀꯣꯞ/ꯚꯦꯂꯤꯗꯤꯇꯤ); ꯁꯤ.ꯑꯦ.ꯄꯤ.ꯑꯦ.ꯒꯤ ꯁ꯭ꯇꯦꯇꯁꯀꯥ ꯂꯣꯌꯅꯅꯥ ꯑꯔꯣꯏꯕꯥ ꯑꯦꯟ.ꯕꯤ./ꯑꯦꯝ.ꯗꯤ.ꯑꯦꯁ.ꯑꯦ.ꯄꯤ.ꯒꯤ ꯑꯣꯗꯤꯠꯀꯤ ꯁꯣꯃꯥꯔꯤꯁꯤꯡ; ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.ꯒꯤ ꯃꯦꯄꯤꯡ ꯃꯦꯃꯣ; UDI ꯂꯦꯕꯦꯂꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯗꯦꯇꯥꯕꯦꯖ ꯁ꯭ꯛꯔꯤꯅꯁꯇꯁꯤꯡ (US GUDID/EU Eudamed)꯫

• ꯑꯣꯄꯔꯦꯁꯅꯁꯤꯡ & ꯚꯦꯂꯤꯗꯦꯁꯟ: ꯗꯤ.ꯑꯦꯝ.ꯑꯥꯔ./ꯗꯤ.ꯑꯩꯆ.ꯑꯦꯐ./ꯗꯤ.ꯑꯩꯆ.ꯑꯥꯔ.ꯒꯤ ꯈꯨꯗꯃꯁꯤꯡ; ꯚꯦꯂꯤꯗꯦꯁꯟ ꯃꯥꯁ꯭ꯇꯔ ꯄ꯭ꯂꯥꯟ; ꯔꯤꯞꯔꯖꯦꯟꯇꯦꯇꯤꯕ ꯑꯥꯏ.ꯀ꯭ꯌꯨ./ꯑꯣ.ꯀ꯭ꯌꯨ./ꯄꯤ.ꯀ꯭ꯌꯨ.ꯒꯤ ꯄꯦꯀꯦꯖ; ꯁꯣꯐꯇꯋꯥꯌꯔ ꯑꯦꯁꯨꯔꯦꯟꯁꯀꯤ ꯑꯣꯚꯔꯚꯤꯌꯨ; ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯑꯥꯎꯠꯂꯥꯏꯟ (ꯏ.ꯑꯣ./ꯔꯦꯗꯤꯑꯦꯁꯟ/ꯁ꯭ꯇꯤꯝ) ꯑꯃꯁꯨꯡ ꯄꯦꯀꯦꯖꯤꯡ ꯚꯦꯂꯤꯗꯦꯁꯟ꯫

• ꯗꯦꯂꯤꯕꯔꯤ & ꯀꯝꯃꯔꯁꯤꯑꯦꯜ: ꯊꯥ ꯱꯲ꯒꯤ ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.ꯀꯤ ꯇ꯭ꯔꯦꯟꯗ; ꯏꯃꯨꯡꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯁ꯭ꯇꯦꯟꯗꯔꯗ ꯂꯤꯗ ꯇꯥꯏꯃꯁꯤꯡ (ꯁ꯭ꯇꯣꯛ ꯕꯅꯥꯝ ꯀꯁ꯭ꯇꯝ); ꯑꯦꯝ.ꯑꯣ.ꯀ꯭ꯌꯨ.ꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯏꯅꯚꯦꯟꯇꯔꯤ ꯄꯣꯂꯤꯁꯤ; ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯦ./ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇ, ꯇꯨꯂꯤꯡ/ꯑꯥꯏ.ꯄꯤ.ꯒꯤ ꯀ꯭ꯂꯣꯖꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯋꯥꯔꯦꯟꯇꯤ/ꯔꯤꯇꯔꯅꯁꯤꯡ ꯗ꯭ꯔꯥꯐ ꯇꯧꯕꯥ꯫

ꯑꯣꯊꯣꯔꯤꯇꯤ ꯑꯣꯏꯕꯥ ꯕꯦꯀꯒ꯭ꯔꯥꯎꯟꯗꯒꯤꯗꯃꯛ: ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯍꯕ (ꯃꯣꯗꯦꯂꯤꯇꯤꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯑꯦꯁ.ꯑꯦ.ꯑꯦꯜ.) ꯑꯃꯁꯨꯡ ꯕꯤ.ꯑꯦꯁ.ꯑꯥꯏ ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯅꯒꯤ ꯑꯣꯚꯔꯚꯤꯌꯨ꯫.

ꯑꯦꯐ.ꯑꯦ.ꯀ꯭ꯌꯨ.: ꯑꯩꯈꯣꯌꯅꯥ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯍꯦꯟꯅꯥ ꯇꯥꯕꯥ ꯄ꯭ꯔꯣꯛꯌꯨꯔꯃꯦꯟꯇꯀꯤ ꯋꯥꯍꯪꯁꯤꯡ꯫

ꯋꯥꯍꯪ : ꯑꯥꯏ.ꯑꯦꯁ.ꯑꯣ.꯱꯳꯴꯸꯵ ꯑꯃꯁꯨꯡ ꯁ꯭ꯀꯣꯄꯀꯤꯗꯃꯛ ꯑꯩꯈꯣꯌꯅꯥ ꯀꯔꯤ ꯗꯣꯀꯨꯃꯦꯟꯇ ꯔꯤꯛꯕꯦꯁ꯭ꯠ ꯇꯧꯒꯗꯒꯦ? ꯎ: ꯏꯁꯨ ꯇꯧꯔꯤꯕꯥ ꯃꯤꯑꯣꯏ, ꯅꯝꯕꯔ, ꯁ꯭ꯀꯣꯞ (ꯏꯃꯞꯂꯥꯟꯇꯁꯤꯡ/ ꯏꯅꯁ꯭ꯠꯔꯨꯃꯦꯟꯇꯁꯤꯡꯒꯤ ꯃꯌꯦꯛ ꯁꯦꯡꯅꯥ ꯗꯤꯖꯥꯏꯟ/ꯃꯦꯟꯌꯨꯐꯦꯀꯆꯔ ꯇꯧꯕꯥ), ꯑꯃꯁꯨꯡ ꯚꯦꯂꯤꯗꯤꯇꯤꯒꯤ ꯇꯥꯡꯁꯤꯡ, ꯑꯃꯁꯨꯡ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯅꯧꯕꯥ NB/MDSAP ꯑꯣꯗꯤꯠ ꯁꯣꯃꯥꯔꯤꯁꯤꯡ ꯑꯃꯁꯨꯡ CAPA ꯀ꯭ꯂꯣꯖꯑꯥꯎꯠ ꯁ꯭ꯇꯦꯇꯁꯀꯥ ꯂꯣꯌꯅꯅꯥ ꯁꯔꯇꯤꯐꯤꯀꯦꯠ ꯄꯤ.ꯗꯤ.ꯑꯦꯐ. ꯲꯰꯲꯶ꯀꯤ ꯁꯦꯝ ꯁꯥꯕꯥ ꯁꯣꯏꯗꯅꯥ ꯐꯪꯍꯟꯅꯕꯥ ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ. ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ.ꯒꯤ ꯑꯦꯐ.ꯑꯦ.ꯀ꯭ꯌꯨ.ꯁꯤꯡ ꯌꯦꯡꯕꯤꯌꯨ꯫.

ꯋꯥꯍꯪ : ꯑꯩꯈꯣꯌꯅꯥ ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯌꯨ.ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯥꯔ. ꯑꯃꯁꯨꯡ ꯏ.ꯌꯨ.ꯒꯤ ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ. ꯎ: ISO 13485/QMSR ꯑꯁꯤ ꯀꯣꯔ QMS ꯕꯦꯖ ꯂꯥꯏꯟ ꯑꯣꯏꯅꯥ ꯂꯧ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯅꯍꯥꯛꯀꯤ NBꯅꯥ ꯃꯊꯧ ꯇꯥꯕꯒꯤ ꯃꯇꯨꯡꯏꯟꯅꯥ MDR-ꯁ꯭ꯄꯦꯁꯤꯐꯤꯛ ꯁꯞꯂꯥꯏꯌꯔ ꯀꯟꯠꯔꯣꯂꯁꯤꯡ (ꯀ꯭ꯔꯤꯇꯤꯀꯦꯜ ꯁꯞꯂꯥꯏꯌꯔ ꯑꯣꯚꯔꯁꯥꯏꯠ, ꯑꯣꯗꯤꯠ/ꯆꯦꯟꯖ ꯔꯥꯏꯇꯁꯤꯡ, ꯇꯦꯛꯅꯤꯀꯦꯜ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯟ) ꯂꯦꯌꯔ ꯇꯧ꯫ ꯕꯤ.ꯑꯦꯁ.ꯑꯥꯏ.ꯅꯥ ꯑꯦꯁ꯭ꯄꯤꯔꯦꯁꯅꯁꯤꯡ ꯑꯗꯨ ꯐꯣꯡꯗꯣꯛꯂꯤ꯫ ꯃꯁꯤꯒꯤ ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯕꯦꯁ꯭ꯠ-ꯄ꯭ꯔꯦꯛꯇꯤꯁ ꯒꯥꯏꯗꯅꯤ꯫.

ꯋꯥꯍꯪ : ꯁ꯭ꯇꯣꯛ ꯇ꯭ꯔꯥꯎꯃꯥ/ꯁ꯭ꯄꯥꯏꯅꯦꯜ ꯑꯥꯏꯇꯦꯃꯁꯤꯡꯒꯤ ꯃꯔꯝ ꯆꯥꯕꯥ ꯂꯤꯗ ꯇꯥꯏꯝ ꯑꯁꯤ ꯀꯔꯤꯅꯣ? ꯎ: ꯃꯁꯤ ꯏꯃꯨꯡ ꯃꯅꯨꯡ ꯑꯃꯁꯨꯡ ꯖꯤꯑꯣꯒ꯭ꯔꯥꯐꯤꯒꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯈꯦꯠꯅꯩ; ꯄ꯭ꯔꯣꯒ꯭ꯔꯥꯝ ꯀꯌꯥꯅꯥ ꯏꯟ-ꯁ꯭ꯇꯣꯛ ꯑꯦꯁ.ꯀꯦ.ꯌꯨ.ꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯅꯨꯃꯤꯠ ꯈꯔꯅꯤꯒꯤ ꯃꯅꯨꯡꯗꯥ ꯅꯨꯃꯤꯠ ꯲ꯗꯒꯤ ꯅꯨꯃꯤꯠ ꯲ ꯐꯥꯑꯣꯕꯥ ꯑꯃꯁꯨꯡ ꯀꯁ꯭ꯇꯝ ꯔꯅꯁꯤꯡꯒꯤꯗꯃꯛꯇꯥ ꯅꯨꯃꯤꯠ ꯴–꯱꯲+ ꯐꯥꯑꯣꯕꯒꯤ ꯃꯅꯨꯡꯗꯥ ꯊꯥꯗꯣꯀꯄꯥ ꯄꯥꯟꯗꯝ ꯊꯝꯂꯤ, ꯑꯗꯨꯕꯨ ꯃꯇꯝ ꯄꯨꯝꯅꯃꯛꯇꯥ ꯀꯦꯇꯦꯒꯣꯔꯤ-ꯂꯦꯕꯦꯜ ꯇꯦꯕꯂꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯤꯄꯃꯦꯟꯇ ꯂꯣꯒꯁꯤꯡ ꯚꯦꯂꯤꯗꯦꯠ ꯇꯧꯏ꯫ ꯅꯍꯥꯛꯀꯤ ꯑꯣ.ꯑꯥꯔ.ꯒꯤ ꯁꯦꯗ꯭ꯌꯨꯜ ꯇꯧꯕꯒꯤ ꯃꯊꯧ ꯇꯥꯕꯁꯤꯡꯒꯥ ꯃꯥꯟꯅꯅꯥ ꯆꯠꯂꯨ ꯑꯃꯁꯨꯡ ꯀꯣꯔꯁ-ꯀꯔꯦꯛꯇ ꯇꯧꯅꯕꯥ ꯊꯥ ꯈꯨꯗꯤꯡꯒꯤ ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.

ꯋꯥꯍꯪ : ꯑꯣ.ꯏ.ꯑꯦꯝ.ꯒꯤ ꯄ꯭ꯔꯣꯒ꯭ꯔꯥꯃꯁꯤꯡꯗꯥ ꯇꯨꯂꯤꯡ ꯑꯃꯁꯨꯡ ꯗꯤꯖꯥꯏꯟ ꯐꯥꯏꯂꯁꯤꯡ ꯀꯅꯥꯅꯥ ꯃꯄꯨ ꯑꯣꯏꯔꯤꯕꯒꯦ? ꯎ: ꯌꯨꯅꯤꯚꯔꯁꯦꯜ ꯅꯣꯔꯝ ꯑꯃꯠꯇꯥ ꯂꯩꯇꯦ꯫ ꯑꯦꯝ.ꯑꯦꯁ.ꯑꯦ./ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯑꯦꯒ꯭ꯔꯤꯃꯦꯟꯇꯇꯥ ꯀꯅꯥꯅꯥ ꯇꯨꯂꯁꯤꯡ ꯑꯃꯁꯨꯡ ꯁꯤ.ꯑꯦ.ꯗꯤ.ꯒꯤ ꯐꯥꯏꯂꯁꯤꯡꯒꯤ ꯃꯄꯨ ꯑꯣꯏꯔꯤꯕꯒꯦ, ꯑꯍꯣꯡꯕꯁꯤꯡ ꯑꯁꯤ ꯀꯔꯝꯅꯥ ꯑꯌꯥꯕꯥ ꯄꯤꯕꯒꯦ, ꯑꯃꯁꯨꯡ ꯂꯣꯏꯁꯤꯅꯕꯗꯥ ꯀꯔꯤ ꯊꯣꯀꯄꯒꯦ ꯍꯥꯌꯕꯗꯨ ꯃꯌꯦꯛ ꯁꯦꯡꯅꯥ ꯇꯥꯀꯄꯥ꯫ ꯏꯟꯇꯔꯅꯦꯜ ꯑꯥꯏ.ꯄꯤ.ꯒꯤ ꯄꯣꯂꯤꯁꯤ ꯑꯃꯁꯨꯡ ꯖꯤ.ꯄꯤ.ꯑꯣ.ꯒꯤ ꯇꯔꯃꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯑꯦꯂꯥꯏꯟ ꯇꯧꯕꯥ; ꯑꯉꯀꯄꯥ ꯄꯣꯀꯍꯟꯗꯅꯕꯥ ꯔꯦꯗꯂꯥꯏꯟ ꯗ꯭ꯔꯥꯐ꯭ꯠ ꯑꯃꯥ ꯇꯣꯌꯅꯥ ꯍꯥꯌꯖꯔꯤ꯫

ꯋꯥꯍꯪ : ꯑꯩꯈꯣꯌꯅꯥ ꯑꯥꯏ.ꯀ꯭ꯌꯨ./ꯑꯣ.ꯀ꯭ꯌꯨ./ꯄꯤ.ꯀ꯭ꯌꯨ.ꯒꯨꯝꯕꯥ ꯄ꯭ꯔꯣꯁꯦꯁ ꯚꯦꯂꯤꯗꯦꯁꯅꯁꯤꯡ ꯀꯗꯥꯏꯗꯥ ꯎꯕꯥ ꯐꯪꯒꯗꯒꯦ? ꯎ: ꯑꯔꯣꯏꯕꯥ ꯏꯟꯁꯄꯦꯛꯁꯟꯅꯥ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯃꯄꯨꯡ ꯐꯥꯅꯥ ꯚꯦꯔꯤꯐꯥꯏ ꯇꯧꯕꯥ ꯉꯃꯗꯕꯥ ꯑꯈꯟꯅꯕꯥ ꯊꯧꯑꯣꯡ ꯑꯃꯍꯦꯛꯇꯒꯤꯗꯃꯛ꯫ ꯔꯤꯞꯔꯖꯦꯟꯇꯦꯇꯤꯕ ꯑꯥꯏ.ꯀ꯭ꯌꯨ./ꯑꯣ.ꯀ꯭ꯌꯨ./ꯄꯤ.ꯀ꯭ꯌꯨ.ꯒꯤ ꯄꯦꯀꯦꯖ ꯑꯃꯥ ꯑꯃꯁꯨꯡ ꯚꯦꯂꯤꯗꯦꯁꯟ ꯃꯥꯁ꯭ꯇꯔ ꯄ꯭ꯂꯥꯟ ꯑꯃꯥ ꯄꯤꯅꯕꯥ ꯍꯥꯌꯕꯤꯌꯨ; ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯀ꯭ꯂꯦꯃꯁꯤꯡ ꯑꯦꯞꯂꯥꯏ ꯇꯧꯕꯥ ꯃꯐꯃꯗꯥ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ/ꯄꯦꯀꯦꯖꯤꯡ ꯚꯦꯂꯤꯗꯦꯁꯅꯁꯤꯡꯒꯥ ꯂꯣꯌꯅꯅꯥ ꯇꯤꯡꯏ꯫

ꯃꯊꯪꯒꯤ ꯈꯣꯡꯊꯥꯡꯁꯤꯡ (ꯁꯤꯉ꯭ꯒꯜ ꯁꯣꯐ꯭ꯠ ꯁꯤ.ꯇꯤ.ꯑꯦ.ꯒꯥ ꯂꯣꯌꯅꯅꯥ)

• ꯆꯥꯡꯗꯝꯅꯕꯥ ꯇꯦꯕꯜ ꯑꯗꯨ ꯅꯍꯥꯛꯀꯤ ꯁ꯭ꯞꯔꯦꯗꯁꯤꯠꯇꯥ ꯀꯣꯄꯤ ꯇꯧ ꯑꯃꯁꯨꯡ ꯃꯦꯊꯣꯗꯣꯂꯣꯖꯤ ꯁꯦꯛꯁꯅꯗꯒꯤ ꯁ꯭ꯀꯣꯔ ꯇꯧꯕꯒꯤ ꯑꯔꯨꯝꯕꯥ ꯍꯥꯄꯆꯤꯜꯂꯨ꯫

• ꯚꯦꯔꯤꯐꯤꯀꯦꯁꯟ ꯆꯦꯀꯂꯤꯁ꯭ꯠ ꯑꯗꯨ ꯅꯍꯥꯛꯀꯤ RFPꯗꯥ ꯑꯦꯇꯦꯆ ꯇꯧ ꯑꯃꯁꯨꯡ ꯚꯦꯂꯤꯗꯦꯁꯟ, ꯇ꯭ꯔꯦꯁꯤꯕꯤꯂꯤꯇꯤ, ꯑꯃꯁꯨꯡ ꯔꯤꯂꯤꯑꯦꯕꯤꯂꯤꯇꯤ ꯏꯚꯤꯗꯦꯟꯁꯇꯥ ꯃꯤꯠꯌꯦꯡ ꯊꯝꯕꯥ ꯁꯥꯏꯠ ꯚꯤꯖꯤꯠ ꯅꯠꯠꯔꯒꯥ ꯚꯔꯆꯨꯑꯦꯜ ꯑꯣꯗꯤꯠ ꯑꯃꯥ ꯁꯦꯗ꯭ꯌꯨꯜ ꯇꯧ꯫

• ꯃꯊꯛꯀꯤ ꯑꯣꯔꯊꯣꯄꯦꯗꯤꯛ ꯑꯣ.ꯏ.ꯑꯦꯝ.ꯒꯤ ꯁꯞꯂꯥꯏꯌꯔ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯑꯗꯨ ꯁꯣꯌꯗꯅꯥ ꯐꯪꯍꯅꯕꯥ ꯉꯝꯕꯥ ꯁꯞꯂꯥꯏꯌꯔꯁꯤꯡ ꯁꯣꯔꯇꯂꯤꯁ꯭ꯠ ꯇꯧ, ꯃꯗꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ. ꯑꯃꯁꯨꯡ ꯗꯣꯛꯌꯨꯃꯦꯟꯇꯦꯁꯟ ꯐ꯭ꯂꯣ ꯀꯅꯐꯥꯔꯝ ꯇꯧꯅꯕꯥ ꯄꯥꯏꯂꯣꯠ ꯄꯤ.ꯑꯣ.

ꯇꯔꯨ ꯇꯅꯥꯅꯕꯥ ꯁꯤ.ꯇꯤ.ꯑꯦ.: ꯍꯦꯗ ꯁ꯭ꯇꯥꯔꯠ ꯑꯃꯥ ꯄꯥꯝꯕꯤꯕꯔꯥ? ꯉꯁꯤ ꯗꯤꯐꯦꯟꯁ ꯇꯧꯕꯥ ꯌꯥꯕꯥ ꯁꯣꯔꯇꯂꯤꯁ꯭ꯠ ꯑꯃꯥ ꯁꯦꯝꯅꯕꯥ ꯃꯊꯛꯀꯤ ꯇꯦꯕꯜ ꯑꯃꯁꯨꯡ ꯀ꯭ꯔꯥꯏꯇꯦꯔꯤꯌꯥ ꯈꯨꯗꯤꯡꯃꯛꯇꯥ ꯑꯥꯔ.ꯑꯦꯐ.ꯄꯤ.

ꯔꯤꯐꯔꯦꯟꯁꯁꯤꯡ (ꯈꯨꯗꯣꯡꯆꯥꯕꯥ, ꯑꯣꯊꯣꯔꯤꯇꯤ ꯑꯣꯏꯕꯥ)

• ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯀ꯭ꯕꯥꯂꯤꯇꯤ ꯃꯦꯅꯦꯖꯃꯦꯟꯇ ꯁꯤꯁ꯭ꯇꯦꯝ ꯔꯦꯒꯨꯂꯦꯁꯟ ꯑꯦꯐ.ꯑꯦ.ꯀ꯭ꯌꯨ.ꯁꯤꯡ — ꯇꯥꯏꯃꯂꯥꯏꯟ ꯑꯃꯁꯨꯡ ꯑꯦꯂꯥꯏꯟꯃꯦꯟꯇ ꯑꯣꯚꯔꯚꯤꯌꯨ꯫ https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-ꯗꯥ ꯌꯥꯝꯅꯥ ꯀꯟꯅꯥ ꯍꯪꯂꯀꯄꯥ ꯋꯥꯍꯪꯁꯤꯡ꯫

• ꯕꯤ.ꯑꯦꯁ.ꯑꯥꯏ.ꯑꯦꯝ.ꯗꯤ.ꯑꯥꯔ.ꯒꯤ ꯗꯣꯀꯨꯃꯦꯟꯇ ꯇꯧꯕꯒꯤ ꯈ꯭ꯕꯥꯏꯗꯒꯤ ꯐꯕꯥ ꯊꯧꯑꯣꯡꯁꯤꯡ — ꯁꯞꯂꯥꯏꯌꯔꯅꯥ ꯀꯟꯇꯦꯛꯁ ꯀꯟꯠꯔꯣꯜ ꯇꯧꯏ꯫ https://www.bsigroup.com/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-mdr-ꯕꯦꯁ꯭ꯠ-ꯄ꯭ꯔꯦꯛꯇꯤꯁ-ꯗꯣꯀꯨꯃꯦꯟꯇꯦꯁꯟ-ꯁꯕꯃꯤꯁꯅꯁꯤꯡ-ꯑꯦꯟ-ꯖꯤ.ꯕꯤ.ꯄꯤ.ꯗꯤ.ꯑꯦꯐ

• ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯁꯤꯁ꯭ꯇꯦꯝ ꯑꯣꯚꯔꯚꯤꯌꯨ ꯑꯃꯁꯨꯡ ꯖꯤ.ꯌꯨ.ꯗꯤ.ꯗꯤ. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/ꯌꯨꯅꯤꯛ-ꯗꯤꯚꯥꯏꯁ-ꯑꯥꯏꯗꯦꯟꯇꯤꯐꯤꯀꯦꯁꯟ-ꯁꯤꯁ꯭ꯇꯦꯝ-ꯎꯗꯤ-ꯁꯤꯁ꯭ꯇꯦꯝ꯫

• ꯏ.ꯌꯨ.ꯒꯤ ꯌꯨ.ꯗꯤ.ꯑꯥꯏ.ꯒꯤ ꯒꯥꯏꯗꯂꯥꯏꯅꯁꯤꯡ (ꯑꯦꯝ.ꯗꯤ.ꯁꯤ.ꯖꯤ.)꯫ https://health.ec.europa.eu/system/files/2021-07/md_2021-19_en_0.pdf.ꯗꯥ ꯐꯣꯉꯗꯣꯛꯂꯤ꯫

• ꯑꯦꯐ.ꯗꯤ.ꯑꯦ.ꯒꯤ ꯁ꯭ꯇꯦꯔꯤꯂꯥꯏꯖꯦꯁꯟ ꯍꯕ — ꯃꯣꯗꯦꯂꯤꯇꯤꯁꯤꯡ, ꯑꯦꯁ.ꯑꯦ.ꯑꯦꯜ., ꯁꯀꯈꯉꯂꯕꯥ ꯁ꯭ꯇꯦꯟꯗꯔꯗꯁꯤꯡ꯫ https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

• ꯑꯣ.ꯇꯤ.ꯑꯥꯏ.ꯑꯦꯐ.ꯕꯨ ꯂꯦꯄꯊꯣꯀꯄꯒꯤ ꯃꯇꯥꯡꯗꯥ ꯃꯦꯀꯏꯅꯁꯦ ꯑꯦꯛꯁꯞꯂꯦꯅꯔ — ꯃꯦꯠꯔꯤꯛ ꯀ꯭ꯂꯦꯔꯤꯇꯤ꯫ https://www.mckinsey.com/capabilities/operations/our-insights/ꯀꯟꯖꯨꯃꯔ-ꯁꯦꯛꯇꯔꯗꯥ-ꯃꯄꯨꯡ ꯐꯥꯅꯥ-ꯃꯇꯝ-ꯃꯇꯝ-ꯗꯥ ꯂꯦꯄꯊꯣꯀꯄꯥ꯫

ꯅꯣꯠ: ꯒꯥꯏꯗꯂꯥꯏꯟ ꯑꯁꯤꯅꯥ ꯅ꯭ꯌꯨꯠꯔꯤꯑꯦꯟꯇ, ꯏꯚꯤꯗꯦꯟꯁ-ꯕꯥꯎꯟꯗ ꯂꯣꯜ ꯁꯤꯖꯤꯟꯅꯩ꯫ ꯃꯃꯜ ꯂꯦꯞꯄꯥ ꯑꯁꯤ ꯁ꯭ꯀꯣꯄꯀꯤ ꯃꯇꯨꯡ ꯏꯟꯅꯥ ꯈꯦꯠꯅꯩ ꯑꯃꯁꯨꯡ ꯃꯍꯧꯁꯥꯅꯥ ꯀꯣꯠ ꯇꯧꯏ; ꯀꯔꯤꯒꯨꯝꯕꯥ ꯔꯦꯟꯖꯁꯤꯡ ꯑꯗꯨ ꯅꯍꯥꯛꯀꯤ RFQꯁꯤꯡꯗꯥ ꯎꯕꯥ ꯐꯪꯂꯕꯗꯤ, ꯃꯈꯣꯌꯁꯤꯡ ꯑꯗꯨ 'from' ꯑꯦꯃꯥꯎꯟꯇ ꯑꯣꯏꯅꯥ ꯄꯤꯌꯨ ꯑꯃꯁꯨꯡ ꯃꯈꯣꯌ ꯑꯁꯤ ꯇꯦꯛꯅꯤꯀꯦꯜ ꯔꯤꯚꯤꯌꯨꯒꯤ ꯃꯇꯨꯡꯗꯥ ꯍꯣꯡꯗꯣꯀꯄꯥ ꯌꯥꯏ ꯍꯥꯌꯅꯥ ꯅꯣꯠ ꯇꯧꯕꯤꯌꯨ.