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Design history file
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#	Item
51	Draft Guidance for Industry and Food and Drug Administration Staff Add to Reading List Source URL: www.fda.gov Language: English Medical equipment Immunologic tests Pharmaceutical industry Food and Drug Administration Dengue fever Design history file Immunoassay Flavivirus Dengue virus Medicine Health Biology
52	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Health Quality Medical equipment Design history file Validation Medical device Design controls Center for Devices and Radiological Health Medicine Technology Food and Drug Administration
53	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Health Quality Medical equipment Design history file Validation Medical device Design controls Center for Devices and Radiological Health Medicine Technology Food and Drug Administration
54	Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Add to Reading List Source URL: www.fda.gov Language: English Technology Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Premarket approval Design controls Quality management system Design history file Title 21 of the Code of Federal Regulations Medical ultrasonography Medicine Food and Drug Administration Health
55	Questions and answers on design space verification Add to Reading List Source URL: www.ema.europa.eu Language: English - Date: 2013-11-21 12:03:22 Quality Evaluation Science Systems science Clinical research Validation Verification Quality by Design Design history file Systems engineering Pharmaceutical industry Validity
56	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Health Food and Drug Administration Pharmaceutical industry Quality Pharmaceuticals policy Global Harmonization Task Force Design controls Medical device Design history file Medicine Technology Medical equipment
57	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Health Food and Drug Administration Pharmaceutical industry Quality Pharmaceuticals policy Global Harmonization Task Force Design controls Medical device Design history file Medicine Technology Medical equipment
58	••• ••• ST. JUDE ••• Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Technology Validity Human development Validation Design history file Food and Drug Administration Attachment theory Corrective and preventive action Pharmaceutical industry Quality Medicine
59	ftl ST. JUDE MEDICAl: ••• . ; Mou co>mooLtnutsoc. Add to Reading List Source URL: www.fda.gov Language: English Science Technology Food and Drug Administration Medicine Quality Validation Design history file Verification and validation Design controls Systems engineering Pharmaceutical industry Validity
60	St. Jude Medical, Implantable Electronics Systems Division Add to Reading List Source URL: www.fda.gov Language: English Validity Technology Food and Drug Administration Medicine Quality control Validation Design history file Verification and validation Design controls Systems engineering Pharmaceutical industry Science

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