Medical Device Development
This document explains how to use a medical device safely and effectively.
What are instructions for use?
This simple machine has a fulcrum, a load, and an effort.
What is a lever?
This process shapes material by pouring it into a mold and letting it harden.
What is casting?
This is the capital of Minnesota.
What is St. Paul?
Founded in the Netherlands in 1891, this company first made products that lit homes and streets.
What are light bulbs?
This activity checks whether a measurement method is suitable for its intended use.
What is measurement system analysis?
This force pulls objects toward Earth.
What is gravity?
This method removes material by cutting, drilling, or grinding.
What is machining?
This famous Minnesota shopping and entertainment complex opened in 1992.
What is the Mall of America?
This father-and-son duo founded Philips in the Dutch city of Eindhoven.
Who are Gerard and Frederik Philips?
This type of study evaluates how people interact with a device and whether they can use it safely.
What is a human factors study?
This type of energy is stored in a stretched spring.
What is elastic potential energy?
This inspection checks a sample of products from a production lot.
What is sampling inspection (lot release)?
This Minnesota city is home to the Mayo Clinic’s main campus.
What is Rochester?
Philips introduced this compact audio format in 1963, helping make music playback portable.
What is the Compact Cassette?
This activity provides documented evidence that a manufacturing process can consistently produce acceptable results.
What is process validation?
This principle says that increasing the length of a lever’s effort arm can reduce the force needed.
What is mechanical advantage?
This manufacturing method builds parts layer by layer from a digital design.
What is additive manufacturing?
This national park in northern Minnesota is known for canoeing and remote lakes.
What is Voyageurs National Park?
Philips and Sony jointly developed this optical disc format, introduced commercially in 1982.
What is the compact disc (CD)?
This document summarizes a medical device’s development, intended use, design, risk controls, and verification and validation evidence.
What is a design history file?
This law states that, at constant temperature, pressure and volume of a gas are inversely related.
What is Boyle’s law?
This production strategy makes products in response to actual demand rather than building them for inventory.
What is make-to-order manufacturing?
This 1894 fire devastated a northeastern Minnesota city and led to widespread rebuilding.
What is the Great Hinckley Fire?
Philips spun off its lighting business, which later became known by this name.
What is Signify?