MDR
MDR stands for this.
What is the Medical Device Regulation?
This country requires type testing of a product in its borders.
What is China?
Lives on the Fox River
Who is Yvonne?
An existing, legally marketed device that may be substantially equivalent to a new medical device
What is a predicate device?
The Beaver is the national animal of this country
What is Canada?
The factor that is used to classify devices
What is potential risk?
This is the governing body responsible for Medical Devices in Brazil
What is ANVISA?
Owns a Fender guitar
Who is John?
An approval of the FDA that will allow devices with substantial equivalence.
What is the 510K approval?
If you roll a standard 6-sided die & a 2 comes up this number is on the bottom
What is 5?
This controversial incident prompted the publication of MDR in 2017.
What is the PIP Breast Implant scandal?
This country is governed by the Department of Health and Aging: Therapeutic Goods Administration (TGA)?
What is Australia?
Who is Julie?
Standard for Quality System for Medical Devices
What is ISO 13485?
These berries flavor gin and are also a nice addition to potpourri
What are Juniper Berries?
This EU MDR Annex describes the requirements for Technical Documentation.
What is Annex II?
The average time to receive 510(k) clearance after submission.
How long is 6 months?
Got into a car accident, hit a police vehicle, and totaled the car
Who is Rishi?
This type of protocol determines if an instrument is installed correctly.
What is IQ (Installation Qualification)?
The creature that kills the most people every year isn't snakes, sharks or even other humans. It is _____.
What is a mosquito?
This clinical document needs to be updated or created prior to launch of a product in Europe and is cited in the Technical Documentation.
What is Clinical Evaluation Report (CER)?
Two of the countries of the Eurasian Economic Union (EAEU), that established a joint registration process
What are Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia
Born in the world's coldest city
Who is Victoria? (The city of Yakutsk)
The meaning of the acronyms RAIS and POF
What is Regulatory Approval Information Sheet and Product Ordering Form?
Shaped like a bow tie this pasta has a name that means butterflies in Italian
What is Farfalle?