D 64 MCT quiz and case studies ISO 14971 Risk management of medical devices - set of documents

This set of four documents covers the requirements for managing medical device (MD) risks according to ISO 14971:2019. This 35-page document kit is a resource to help quality managers and their teams reduce risks and ensure patient safety. The documents are ready to use and editable (Word format) to adapt to your specific context. These documents include 33 multiple-choice tests with answers, 119 questions and answers from the standard requirements quiz, 8 case studies, and 17 true stories. All documents are part of the D 64v19 document set, which are the annexes to the T 64v19 training course, "MD Risk Management."

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	Added the: 24/01/2024 Last update: 11/03/2026 Number of pages: 35 See other documents
	See the training T 64v19 Risk management of MD

You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.

Description

Contents of the set

4 documents (35 pages) designed to help understand and perform risk management of medical devices (MDs) according to ISO 14971 version 2019
detailed content:
- 33 multiple-choice tests
- 8 case studies
- 17 true stories
- 113 questions/answers (quiz requierments)

Use and integration

these documents prepare participants for the requirements of the risk management of MDs, with practical tools to assess and reinforce their knowledge
a paper-based in-class exam is possible, with answers provided at the end

Advantage

the documents are ready to use and editable (Word format) to adapt to the specific needs of each organization

Target audience

risk/quality managers, engineers, and technical teams wishing to implement and improve the risk management of MDs according to ISOI 149871 version 2019

Documents that are part of the document set D 64v19 Risk management of medical devices which is part of the online training Risk management of medical devices T 64v19.

See also the document sets:

Classroom exam paper form with the answers at the end

MCT D 64v19 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 64v19 MCT and case studies Risk maagement of medical devices
Codification	Description	Questions	Pages
PQBD64v19A36	MCT Risk management of MDS	33	10
PQBD64v19A37	Case studies Risk management of MDs	8	8
PQBD64v19A35	Answers quiz requirements Risk management of MDs	113	8
PQBD64v19A38	True stories Risk management of MDs	17	8
PQBD63Menu	Project Risk management of MDs		1
Total		171	35