Black History
First colony to ban slavery in 1777:
A. Massachusetts
B. Pennsylvania
C. Vermont
D. Delaware
What is Vermont?
This ISO specifies quality management system requirements for design, production, and distribution of medical devices.
A. ISO 14971
B. ISO 13485
C. ISO 10993
D. ISO 14155
B. ISO 13485
The following economic operators are required to register electronically under EU MDR.
A) Manufacturer
B) Distributor
C) Authorized Representative
D) Importer
E) All of the Above
What is E) All of the above?
File describing design of a finished device:
A) Device Master Record (DMR)
B) Design History File (DHF)
C) Design History Record (DHR)
D) Risk Management File (RMF)
What is the B) Design History File (DHF)?
An organizational framework that seeks to promote the fair treatment and full participation of all people, particularly groups who have historically been underrepresented or subject to discrimination based on identity or disability
What is DEI
The Brits celebrate Black History Month in this month to honor the contributions and achievements of African Americans:
A) February
B) June
C) September
D) October
What is D) October?
This standard outlines the risk management process for identifying and controlling medical device hazards.
A. ISO 10993
B. ISO 20417
C. ISO 14971
D. ISO 11607
C) ISO 14971
Manufacturers of class IIa medical devices are required to submit which of the following:
A. Post-market surveillance report
B. Periodic safety update report, every two years
C. Periodic safety update report, annually
D. All of the above
E. None of the above
What is B) Periodic safety update report, every two years?
This record documents the actual production history of a specific medical device, ensuring it was manufactured according to the approved specifications and regulatory requirements.
A) Device Master Record (DMR)
B) Design History File (DHF)
C) Design History Record (DHR)
D) Risk Management File (RMF)
What is C) Design History Record (DHR)?
Most racially diverse U.S. generation
What is Generation Z?
Gen Z is the most racially diverse U.S. generation, with approximately 48 percent identifying as non-white.
https://builtin.com/diversity-inclusion/diversity-in-the-workplace-statistics
The first African American child to attend formerly whites-only William Frantz Elementary School in Louisiana during the New Orleans school desegregation crisis on November 14, 1960.
A. Vivian Malone
B. James Meredith
C. James Hood
D. Ruby Nell Bridges Hall
Who is Ruby Nell Bridges Hall?
What is the primary focus of ISO 10993?
A) Mechanical testing of medical devices
B) Electrical safety of medical equipment
C) Biological evaluation of medical devices
D) Software validation for medical devices
What is Biological evaluation of medical devices?
Medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions:
A. Humanitarian Use Device
B. Breakthrough Device
C. Investigational Device
D. Advanced Therapeutic Device
What is a breakthrough device?
Just as a recipe provides detailed instructions and ingredients to prepare a specific dish, the Device Master Record (DMR) provides this for the manufacturing of a medical device:
A) A list of approved materials
B) Detailed manufacturing instructions, production processes, and quality control procedures
C) The design history and development process
D) Post-market surveillance data for device performance
What is B) Detailed manufacturing instructions, production processes, and quality control procedures?
Receive pay raises less often
Who are women?
Women ask for pay raises almost just as often as men at similar positions (at 11 percent for both) — but women receive them about 7 percent less often than men do.
https://builtin.com/diversity-inclusion/diversity-in-the-workplace-statistics
The first woman to run for the Democratic Party’s presidential nomination:
A. Condoleezza Rice
B. Michelle Obama
C. Shirley Chisolm
D. Kamala Harris
Who is Shirley Chisholm?
This statement best reflects the IMDRF's role in global medical device regulation:
A) IMDRF issues legally binding regulations that all member countries must enforce.
B) IMDRF develops harmonized guidance documents to align regulatory approaches across jurisdictions
C) IMDRF primarily focuses on post-market surveillance and does not influence pre-market requirements.
D) IMDRF directly approves medical devices for international market access.
What is B) IMDRF develops harmonized guidance documents to align regulatory approaches across jurisdictions?
Main access key for device-related information in the Eudamed database
A. Serial Number
B. BUDI - DI
C. SRN
D. UDI
What is the BUDI (Basic Unique Device Identifier)?
- UDI is specific to each device version and model, appearing on labels and packaging.
- BUDI-UDI is a broader identifier used for regulatory submissions and grouping devices of the same category.
This process confirms that a device meets its design specifications but does not assess real-world use?
A) Design validation
B) Design verification
C) Design utilization
D) Design transfer
What is B) Design Verification?
The number of Fortune 500 Companies that have a Black CEO
What is 8?
As of 2024, eight Fortune 500 companies have a chief executive officer who is Black.
https://builtin.com/diversity-inclusion/diversity-in-the-workplace-statistics
Inventor of color-changing sutures.
A. Lonnie Johnson
B. Dasia Taylor
C. Lewis Latimer
D. Garrett Morgan
Who is Dasia Taylor ?
At just 17 years old, Dasia Taylor became a nationally recognized scientist by creating color changing sutures that detect infection. Dasia’s invention was centered around equity — her main career focus — and making this life-saving medical technology accessible to everyone.
Her invention uses beets, which change color at different pH levels, as a natural indicator of infection. When beets detect acidity changes in skin, the sutures change from bright red to dark purple. This color change serves as early detection of an infection. Dasia came up with this idea after learning about smart sutures that use technology to detect wound changes and sync to a doctor’s computer or smartphone. Knowing that this expensive technology would not be accessible to people in developing countries – where infection from surgical wounds is comparatively higher — Dasia set out to create a more cost-effective solution.
https://usasciencefestival.org/people/dasia-taylor/
In the context of IEC 60601-1, this is the significance of the term "single fault condition" in the assessment of medical electrical equipment:
A) It defines the maximum number of electrical components that can fail simultaneously without compromising safety.
B) It refers to the worst-case scenario where a single electrical fault leads to an unsafe condition for the patient or operator, and the equipment must continue to perform safely after such a failure.
C) It specifies the level of electrical interference allowed during electromagnetic compatibility testing.
D) It ensures that only one internal fault can occur at a time, preventing any potential cascading failures in the system.
What is B) It refers to the worst-case scenario where a single electrical fault leads to an unsafe condition for the patient or operator, and the equipment must continue to perform safely after such a failure?
List describing allowable levels of insect fragments, rodent hairs mold, whole insects, mammalian excreta or more larvae in food:
A) Codex Alimentarius Commission Food Contaminants Standards
B) FDA's Defect Action Levels for Food
C) European Food Safety Authority (EFSA) Acceptable Contaminant Limits
D) International Organization for Standardization (ISO) 22000 Food Safety Management Guidelines
What is B) Food Defection Action Level?
According to the Quality System Regulation, re-testing and re-evaluation of nonconfomring medical devices must be documented in the:
A) Device History Record
B) Device Master Record
C) Quality Manual
D) Design History File
What is A) Device History Record?
Over 90% of U.S. employees have experienced this.
What is discrimination?
Over 90 percent of U.S. workers have experienced some form of discrimination in the workplace, based on race, gender, disability status, age and other factors.
https://builtin.com/diversity-inclusion/diversity-in-the-workplace-statistics