ClassATG-000025StockRecoveryCompatibilityand safetyComponentchange:deletion ofcolor/flavorProposedand finalEU RegsAmandaWebbAs soon asEthicalCommitteeapproval isreceivedISO15223NoReportingRequiredACEDatabase4Initiate aCAPAprocessBlueGuideBS EN1041FailuremodeeffectsMedicalDevicesand IVDReviseLabelingGaryFaheyPredicateDeviceDesignMakeit FunISO13485 &ISO14971ERC/GSPR7ReprocessingFacilityOrangeBookTraceabilityindistributionEntrepreneurialspiritMostClass I,someclass IIFDA(FURLS)sectionLabelingSterilizationSpecial510KEconomicOperatorsMarioWijker60DaysTraditionalorAbbreviated510KRiskanalysisCarcinogenicityTechnicalDocumentationCA -NetherlandsLabelingReconciliationTrueClassI15thJune2018Relevancetoguidelines21CFRPart820MAUDEFalseTG-000027Local HAGuidelinesEUMEDDEV2.7.1ISO10993EUMDRControl ofdocumentsand controlof recordsLiamKellyClassATG-000025StockRecoveryCompatibilityand safetyComponentchange:deletion ofcolor/flavorProposedand finalEU RegsAmandaWebbAs soon asEthicalCommitteeapproval isreceivedISO15223NoReportingRequiredACEDatabase4Initiate aCAPAprocessBlueGuideBS EN1041FailuremodeeffectsMedicalDevicesand IVDReviseLabelingGaryFaheyPredicateDeviceDesignMakeit FunISO13485 &ISO14971ERC/GSPR7ReprocessingFacilityOrangeBookTraceabilityindistributionEntrepreneurialspiritMostClass I,someclass IIFDA(FURLS)sectionLabelingSterilizationSpecial510KEconomicOperatorsMarioWijker60DaysTraditionalorAbbreviated510KRiskanalysisCarcinogenicityTechnicalDocumentationCA -NetherlandsLabelingReconciliationTrueClassI15thJune2018Relevancetoguidelines21CFRPart820MAUDEFalseTG-000027Local HAGuidelinesEUMEDDEV2.7.1ISO10993EUMDRControl ofdocumentsand controlof recordsLiamKelly

Regulatory Roundup - Call List

(Print) Use this randomly generated list as your call list when playing the game. Place some kind of mark (like an X, a checkmark, a dot, tally mark, etc) on each cell as you announce it, to keep track. You can also cut out each item, place them in a bag and pull words from the bag.


1
N
2
O
3
G
4
G
5
G
6
I
7
O
8
I
9
N
10
I
11
O
12
O
13
G
14
I
15
N
16
G
17
N
18
G
19
O
20
B
21
G
22
O
23
N
24
I
25
O
26
G
27
B
28
G
29
O
30
B
31
O
32
G
33
I
34
B
35
O
36
O
37
I
38
B
39
N
40
N
41
I
42
I
43
G
44
B
45
B
46
O
47
G
48
N
49
B
50
B
51
O
52
I
53
N
54
N
55
N
56
N
57
O
  1. N-Class A
  2. O-TG-000025
  3. G-Stock Recovery
  4. G-Compatibility and safety
  5. G-Component change: deletion of color/flavor
  6. I-Proposed and final EU Regs
  7. O-Amanda Webb
  8. I-As soon as Ethical Committee approval is received
  9. N-ISO 15223
  10. I-No Reporting Required
  11. O-ACE Database
  12. O-4
  13. G-Initiate a CAPA process
  14. I-Blue Guide
  15. N-BS EN 1041
  16. G-Failure mode effects
  17. N-Medical Devices and IVD
  18. G-Revise Labeling
  19. O-Gary Fahey
  20. B-Predicate Device
  21. G-Design
  22. O-Make it Fun
  23. N-ISO 13485 & ISO 14971
  24. I-ERC/GSPR
  25. O-7
  26. G-Reprocessing Facility
  27. B-Orange Book
  28. G-Traceability in distribution
  29. O-Entrepreneurial spirit
  30. B-Most Class I, some class II
  31. O-FDA (FURLS) section
  32. G-Labeling
  33. I-Sterilization
  34. B-Special 510K
  35. O-Economic Operators
  36. O-Mario Wijker
  37. I-60 Days
  38. B-Traditional or Abbreviated 510K
  39. N-Risk analysis
  40. N-Carcinogenicity
  41. I-Technical Documentation
  42. I-CA - Netherlands
  43. G-Labeling Reconciliation
  44. B-True
  45. B-Class I
  46. O-15th June 2018
  47. G-Relevance to guidelines
  48. N-21CFR Part 820
  49. B-MAUDE
  50. B-False
  51. O-TG-000027
  52. I-Local HA Guidelines
  53. N-EU MEDDEV 2.7.1
  54. N-ISO10993
  55. N-EU MDR
  56. N-Control of documents and control of records
  57. O-Liam Kelly