21 CFR Part 820 - US FDA Quality System Regulations (QSR)

21 CFR (Code of Federal Regulations) Part 820 related discussions.
FAQs
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Finding Medical Device Listing Numbers on the USA's FDA site
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19
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29,977
Ronen E
Sidney Vianna
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FDA plans to use ISO 13485 for Medical Devices Regulation
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8
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1,284
Marcelo Antunes
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
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6
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5,023
Julie O
Marc
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ISO 13485, ISO 14971 and other Medical Device Related Forums
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7,858
Marc
Ajit Basrur
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
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12,056
Ajit Basrur
Discussions
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FDA Registration Requirements for Multiple Sites
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5
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65
Ajit Basrur
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PMS template for FDA submission (De novo submission for a Class II IVD)
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3
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50
Ronen E
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Questions about the contents of a Design History File
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3
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70
Ronen E
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Private Label Requirements, Manufacturer's Registration & Initial Importers
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2
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51
Simon
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510(K) for an Entire System vs. Separate 510(K) for each Sub-System
2
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10
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2,102
primavesvera
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Class 1 Medical Device - Using a UPC over the UDI?
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0
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63
jkc3usc
A
Does any one have FDA 21 CFR Part 820 QSR training material?
2
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13
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3,426
Marc
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Do we still have to put UDI if we have DI and lot number seperately on our product ?
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4
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114
Ronen E
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Which batches should or could be considered for design validation and design verification?
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0
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75
v9991
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Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems
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2
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69
Hemanth Kumar
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De Novo Applications since July 2012
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3
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1,135
Watchcat
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Determining Sample Size in Design V&V activities
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44
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11,267
Ronen E
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US Manufacturer of Export Only Exempt Products applying for CFG
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0
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47
jerryz
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Independence of DQA (Design Quality Assurance)
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1
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95
Ronen E
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Two Payment Identification Number (PIN) for the same order in DFUF website
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1
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119
Ajit Basrur
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