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chevron Technical File (TF) closed folder
3ddc78ce06a0c9a45f62b04c02 Not available in current plan. Book a free demo
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chevron Design Input (DI) closed folder
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2248f28508c1ddc8e3a74f944b24466e4ce6ad34db Not available in current plan. Book a free demo
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9e3cc8d755829708552e9d897def9c66738b70 Not available in current plan. Book a free demo
chevron Risk Management File (RM) closed folder
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chevron Usability File / Human factors (HF) closed folder
486ce04ea84f72d3e45b42bdbffb10a529bfe6e10966 Not available in current plan. Book a free demo
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chevron Clinical Evaluation (CE) closed folder
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chevron Post-Market-Clinical-Follow-Up (CF) closed folder
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chevron Development (PD) closed folder
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chevron IVD-Performance Evaluation (PE) closed folder
4bd8438a9c2614c320cf1b2c60390e1b9a988c66 Not available in current plan. Book a free demo
75f73861bf7bc4868cb003a28dfadc06b9b5fa5e0e Not available in current plan. Book a free demo
93070418ba835caf5eadbb1e52f764fa63d7b0 Not available in current plan. Book a free demo
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bb8785c3bd0d6b15e1390dc3450f645019543ec350 Not available in current plan. Book a free demo
11d35981ef93bae254a63141d7a3d9dc5cf8d9afb198 Not available in current plan. Book a free demo
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67b18f40d3fa65af7d6893 Not available in current plan. Book a free demo
7494f8abd6d4255853e0e978 Not available in current plan. Book a free demo
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347cdee1fca73eb88ff94d6ce63d4f032afbd5eb Not available in current plan. Book a free demo
6c44c0247b7f007a16966435c0abb495405bae Not available in current plan. Book a free demo
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b9961d45152de2a3b405e589c5fc54c1ec998d00718a6d8b Not available in current plan. Book a free demo
chevron Labeling (LA) closed folder
58e799739cd5b20ad1f0087944cd5b3fd14857ee222c9a Not available in current plan. Book a free demo
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chevron Biocompatibility (BC) closed folder
1437a1f2063561b196beddea589588efdc14f0b4ac34 Not available in current plan. Book a free demo
4f57fab3b7be3cbddde3abd9e1454a63eb642f33 Not available in current plan. Book a free demo
Name Comment Information EN Latest update
chevron QM-Manual (QM) closed folder
0528e4e52939e4d6f182e4 Not available in current plan. Book a free demo
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chevron Management Review & Audit (MR / IA / UA) closed folder
da06d12d5e32763fd57f5019b2900c Not available in current plan. Book a free demo
9d829ecb85cdfab0c92bd06730 Not available in current plan. Book a free demo
bc978e2e52c745f509adfc0213a653f16d18fc Not available in current plan. Book a free demo
f4eba08eab8bb8c032b856e9b7 Not available in current plan. Book a free demo
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chevron Corrective and preventive actions (CA) closed folder
d77ca1e35af657421650811932b864378e6a68cf206bf3 Not available in current plan. Book a free demo
64e268c02b5ad9c86559c4 Not available in current plan. Book a free demo
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chevron Document & Record Control (DC) closed folder
f4323cc35fdeb0837c579d18a8a5f753f7214de78e4699 Not available in current plan. Book a free demo
e3855f3223a42fe16441db35df Not available in current plan. Book a free demo
9551cd8bb11788e4fb4549139b62b1302701ffefb4f6d9c5f7 Not available in current plan. Book a free demo
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chevron Human Resources & Training (HR) closed folder
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chevron Infrastructure (IS) closed folder
6a3640536abb42c82950f01638f59012a2686447 Not available in current plan. Book a free demo
ef3775b08be7c1ca74021f246ac05bb9 Not available in current plan. Book a free demo
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chevron Development and Product Management closed folder
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chevron Supplier Management & Procurement (SA, PS) closed folder
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chevron Production & Service Delivery (SU, PR, LA, PSA, LG) closed folder
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chevron Change Management (CC) closed folder
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chevron Post-Market Surveillance, Feedback (CH, PM) closed folder
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chevron Authorities and Regulatory Affairs (TF, RU, VI) closed folder
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