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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	Added the: 24/01/2024 Last update: 30/01/2024 Number of pages: 27 See other documents

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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