Infosys Certified Medical Devices Testing Professional
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Real Lex exam-pattern multiple-choice questions for the Infosys Certified Medical Devices Testing Professional certification. Each question includes the correct answer. The full question bank is available to Premium members.
- Question 1
FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices is termed as_______?
- ✓Premarket NotificationCorrect
- BPremarket Approval
- CLabeling
- DQuality System
- Question 2
____________ doesn't talk about "regulatory" requirements awareness?
- ✓ISO 9001Correct
- BISO 13485
- CISO 14971
- DNone of the Choices
- Question 3
_____________ International Standard deals with application of risk management to medical devices?
- ✓SOXCorrect
- BISO 14971
- CHIPPA
- DNone of the Choices
- Question 4
IEC 60601-1-4 deals with?
- ✓Software supporting the medical devices.Correct
- BBasic safety and essential performance that is generally applicable to Health Care professional.
- CBasic safety and essential performance that is generally applicable to medical electrical equipment.
- DNone of the Choices.
- Question 5
Medical Electrical Equipment Part 1: General Requirements for Safety. Part
Programmable Electrical Medical Systems. This International Standard is described in? - ✓IEC 61601-1-4Correct
- BIEC 61610-1-4
- CIEC 60610-1-4
- DIEC 60601-1-4
- Question 6
IEC 62304 does not cover which of the following?
- ✓Validation and final release of the medical device, even when the medical device consists entirely of software.Correct
- BDevelopment and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device.
- CLife cycle requirements for medical device software.
- DCovers all of the Choices.
- Question 7
ISO/IEC 15288 Describes?
- ✓A common framework for describing the life cycle of systems created by humans.Correct
- BIt defines a set of processes and associated terminology.
- CThose systems that are man made and may be configured with one or more of the following: hardware, software, humans, or processes and Processes that support the definition, control and improvement of the life cycle processes used within an organization or a project.
- DAll of the Choices.
- Question 8
State True/False. There is no provision for Electronic Signatures in '21 CFR Part 11'.
- ✓trueCorrect
- Bfalse
- Question 9
"Federal regulation to ensure the security and integrity of electronic clinical data submitted for all regulatory purposes" - is covered in which standard?
- ✓ISO 13485Correct
- BISO 9001
- C21 CFR Part 11
- DNone of the Choices
- Question 10
What is the significance of the following statements: a. Copying of the password should not be allowed. b. The password should have defined validity. It should be ensured that password issuance are periodically changed, recalled or revisited to cover such events as password aging. If the password is not changed by the stipulated timeframe the user account must get locked. c. When the electronic signature of one user is to be administered by another user, then a joint signature of two other users is needed. d. User password should not be accessible to administrator.
- ✓All the statements are the best practices and ought to be followedCorrect
- BAll the statements are requirements of CFR Part 11
- CAll the statements are as per recommendations by NASCOM
- DNone of the Choices
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