Black History
First colony to ban slavery in 1777
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
E) All of the above
File describing design of a finished device
What is the 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
An opportunity to spotlight and celebrate the achievements that African Americans have accomplished in this country, despite the history of racism and oppression.
What is Black History month?
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
B. Periodic safety update report, every two years
What is a 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.
Who is Ruby Nell Bridges Hall?
Standard pertaining to biocompatibility
What is ISO 10993
Medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions
What is a breakthrough device?
Compilation of records containing the procedures and specifications of a finished device
What is the Device Master Record (DMR)?
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
Who is Shirley Chisholm?
Standard for Clinical Evaluation
IMDRF MDCE WG/N56FINAL: 2019
A code that identifies a medical device.
What is UDI (Unique Device Identifier)?
What process confirms that the design output meets the design input requirements.
What is 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.
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/
Standard for Medical electrical equipment
IEC-60601
List describing allowable levels of insect fragments, rodent hairs mold, whole insects, mammalian excreta or more larvae in food.
What process demonstrates the device works as intended for the end user.
Design Validation
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