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What branch of the US government is responsible for the regulation of medical devices?
Department of Health and Human Services
What class of medical devices does an adhesive bandage belong to?
What class of medical devices does a surgical drape belong to?
True or False? All medical devices are subject to general controls.
Which of the following are considered to be the minimal requirements for general controls? (pick all that are applicable)
Device labeling, Manufacturing per cGMP, Manufacturing registration
True or False? Software cannot be considered a medical device.
Why would you use design control in the development of a medical device? (Choose all that apply)
Systematic approach, Required by law, Customer focused, Allows multidisciplinary input
True or False? Planning is not mandated by 21 CFR 820.30, but it will help you complete the project on time, within budget, and using the allocated resources.
A design project does not have to contain the following?
What class of medical devices does a replacement heart valve belong to?
Devices are regulated by the FDA according to the:
risks posed by their use
True or False? Over 90% of the devices placed on the market in the US are cleared by the FDA after the review of a PMA (pre-market approval).
Sections 201(g) and 201(h) of the FD&C Act provide definitions for the terms "drug" and "device". What is the main difference between the two?
Drugs achieve their effect through chemical action and is dependent upon being metabolized
True or False? 510(k) submissions never require any data collected in clinical investigations.
Choose all that apply. A device is considered substantially equivalent (SE) if it:
has the same intended use as the predicate and the same technological characteristics, has the same intended use as the predicate but different technological charactersitcs and the information submitted to the FDA does not raise new questions about safety and efficacy and demonstrates the device is at least as safe and effective as the legally marketed device
Choose all that apply. Which of the following devices are not exempt from 510(k) notification?
All are exempt
True or False? Class III devices are never eligible for 510(k) clearance.
Choose all the apply. Class I devices are not intended to
be used in supporting or sustaining life, present a potential unreasonable risk of illness or injury, be of importance in preventing impairment to human life
The phrase the "voice of the customer" refers to what aspect of design and development:
Development of user needs
Which of the following is NOT considered intellectual property?
All are considered intellectual property, Patent, Trademark, Copyright, Trade Secret
Pick all that apply. Which of the following are a type of patent?
Design patent, Plant patent, Utility patent
True or False? A need statement should have a quantifiable metric associated with it.
How many years does a utility patent last from the non-provisional patent filing date?
True or False? After the patent terms expire, the invention becomes 'public domain' and may be made, used or sold by anyone without licensing.
True or False? A needs statement should have a conceptual solution embedded into it.
Before deciding on a project and developing design requirements, the team must:
Define the problem
Define the need
True or False? Requirements are often measurable.
Audible by someone with unimpaired hearing in a mixed frequency 80 dB environment
1 W speaker driven at 3 V, 2000 Hz for 2 sec/1 sec intermittent
Audible in a noisy environment
True or False? It's OK for a requirement to be vague, ambiguous, or conflicting.
What is the duration (in years) of a patent from the earliest effective filing date in the United States of America?
True or False? Patents are automatically enforced by the USPTO.
What is design validation?
Ensuring that the developed medical device conforms to user needs and intended uses
The minimum requirements for obtaining a patent are that the invention must be:
Novel, non-obvious or include an inventive step, useful or capable of industrial application
If you want to know what is actually covered by a granted patent, what should you look at?
What does ANSI Y.14.5 (Now renamed to ASME Y14.5) relate to?
Dimensioning and tolerancing
All of the following are characteristic of a patent drawing except:
How can properly implemented GD&T save money in the manufacturing process?
Better definition of the design requirements, increased availability of tolerances, better communication between design, manufacturing and inspection, fewer engineering changes.
Fill in the blanks: A specification consists of a
Metric and a value
Fill in the blank: Product design specifications must be specific in translating and interpreting __________ into engineering, quantifiable terms.
Put the following components of the design process in orderCorrect!
User needs in user terms, Marketing requirements are measureable, Specifications provide the details to build, Prototype is built to specifications, Verification testing ensures prototype(specifications) meets requirements
What is the significance of a traceability matrix in medical device design? (Choose all that apply)
Basic design control tool used to establish clear linkages between design inputs, ouputs, verifications, validations, and risk analyses, Required by the FDA
A design review is an examination of a design or process that is: (choose all that apply)
used to bring a cross-functional team to the table to ensure the design team has not missed something overall, documented, an ongoing part of the entire design process,
The objectives of a design review include all of the following except: (choose all that apply)
educate or bring new employees or unprepared employees up-to-speed, evaluate individual team member contributions to the project
At what point during the medical device design process must risk management take place?
Ongoing during the entire process
Risk index (R) =_____ index x ______index
S severity, P likelihood
Identify the regions of the following risk index graph:
Broadly acceptable, ALARP region, Intolerable region
Why do medical devices fail and therefore impose risk on the user? (Choose all that apply)
Quality assurance deficiencies, Design deficiencies, Misuse
What's the purpose for conducting a risk analysis? (Choose all that apply)
Reduce product liability and damage awards, Reduce probability of having a recall, Required in PMA and 510(k) filings, Required by law
________is used to identify a failure/safety hazard and all possible ways to create that hazard, while__________assumes a basic defect on a component level, assesses the effect and identifies potential solutions.
Which of the following ISO standards applies to risk management?
Which of the following ISO standards applies to biocompaitbility?
Broadly acceptable level of risk determination is driven by:
True or False? Accuracy is a measure of the total error.
True or False? Reproducibility and precision imply accuracy.
Leakage current is (choose all that apply)
the current that passes through the patient's body in the course of device operation, the current that passes through the caregiver's body in the course of device operation
True or False? Grounding is not required for Class I equipment.
True or False? Class II electrical instruments use "live" and "neutral" connections only.
Rank the following applied part types in the order of increasing electrical protection:Correct!
B, BF, CF
Which of the following statements is true?
Leakage currents are measured during both normal and single fault conditions
Electrical safety must be tested: (Choose all that apply)
on newly acquired equipment prior to being accepted for use, during routine planned preventative maintenance, after repairs have been carried out on equipment
Electrical shock may result from:
one part of the body being in contact with a conductive surface, a different part of the same body being in contact with a second conductive surface, a voltage source driving current through the body between those two points of contacts
four design laws
multidisciplinary team based, customer focused, robust, systematic approach
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