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D 54 MCT quiz and case studies ISO 14971 Risk management of medical devices - set of documents

MCT (multiple choice test) and case studies of your online training module Risk management of medical devices with 154 questions, answers and comments

 
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D 54 MCT quiz and case studies ISO 14971 Risk management of medical devices - set of documents
  • Added the: 24/01/2024
  • Last update: 30/01/2024
  • Number of pages: 27
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Description

 Documents that are part of the document set D 54v19 Risk management of medical devices which is part of the online training Risk management of medical devices T 54v19

 Classroom exam paper form with the answers at the end

 

MCT D 54v19 Risk management of medical devices
 
  • Presentation
  • MCT (multiple-choice test) Beginning, 10 questions, (can be seen on the free demo)
  • 1 Risk
    • 1.1 History
    • 1.2 Scope
    • 1.3 Benefits
  • 2 Definitions, standards and books
    • 2.1 Definitions
    • 2.2 Standards
    • 2.3 Books
  • 3 Process approach
    • 3.1 Types
    • 3.2 Mapping
    • 3.3 Process approach
  • 4 General requirements 
    • 4.1 Risk management
    • 4.2 Responsibilities
    • 4.3 Competences
    • 4.4 Risk management plan
    • 4.5 Risk management file
  • Summary of clause 4
  • MCT General requirements, 9 questions, (can be seen on the free demo)
  • 5 Risk analysis
    • 5.1 Risk analysis
    • 5.2 Use
    • 5.3 Characteristics
    • 5.4 Hazards
    • 5.5 Estimation
  • Summary of clause 5
  • MCT Risk analysis (6 questions)
  • 6 Risk evaluation
  • Case New risk
  • Case Risk register
  • Case Risk treatment
  • Summary of clause 6
  • 7 Risk control
    • 7.1 Options 
    • 7.2 Control measures
    • 7.3 Residual risks
    • 7.4 Benefit-risk
    • 7.5 Risks from risk control
    • 7.6 Completeness of control
  • Case Kaizen and problem
  • Case Control measure
  • Case Acceptability criteria
  • Summary of clause 7
  • MCT Risk evaluation and control (6 questions)
  • 8 Overall residual risk
  • Summary of clause 8
  • 9 Risk management review
  • Summary of clause 9
  • MCT Management review (6 questions)
  • 10 Production and post-production
    • 10.1 General 
    • 10.2 Collection
    • 10.3 Review
    • 10.4 Actions
  • Case Nonconformities
  • Summary of clause 10
  • MCT Production and post-production (6 questions)
  • MCT End (20 questions)

 

D 54v19 MCT and case studies Risk maagement of medical devices
Codification Description Questions Pages
PQBD54v19A36 MCT Risk management of MDS 33 10
PQBD54v19A37 Case studies Risk management of MDs 8 8
PQBD54v19A35 Answers quiz requirements Risk management of MDs 113 8
PQBD53Menu Project Risk management of MDs   1
Total 154 27