Human Factors Benefit- Risk Analysis Technical Documentation State of the Art Change Control Traceability Performance Evaluation CE Marking Family Legal Manufacturer Design Review Design History File Class D Design Freeze Design Outputs ISO 14971: 2019 Risk Management Verification Design Inputs Competent Authority Stability Study IVDR User Requirements Specification (URS) Instructions for Use Scientific Validity Requirements Class B Free! ISO 13485: 2016 Clinical Performance Regulatory Compliance Class C Validation UDI Design Transfer EUDAMED Safety Quality by Design Labeling Notified Body Shelf Life Authorized Representative Usability Engineering Intended Purpose Design Control Analytical Performance Human Factors Benefit- Risk Analysis Technical Documentation State of the Art Change Control Traceability Performance Evaluation CE Marking Family Legal Manufacturer Design Review Design History File Class D Design Freeze Design Outputs ISO 14971: 2019 Risk Management Verification Design Inputs Competent Authority Stability Study IVDR User Requirements Specification (URS) Instructions for Use Scientific Validity Requirements Class B Free! ISO 13485: 2016 Clinical Performance Regulatory Compliance Class C Validation UDI Design Transfer EUDAMED Safety Quality by Design Labeling Notified Body Shelf Life Authorized Representative Usability Engineering Intended Purpose Design Control Analytical Performance
(Print) Use this randomly generated list as your call list when playing the game. There is no need to say the BINGO column name. Place some kind of mark (like an X, a checkmark, a dot, tally mark, etc) on each cell as you announce it, to keep track. You can also cut out each item, place them in a bag and pull words from the bag.
Human Factors
Benefit-Risk Analysis
Technical Documentation
State of the Art
Change Control
Traceability
Performance Evaluation
CE Marking
Family
Legal Manufacturer
Design Review
Design History File
Class D
Design Freeze
Design Outputs
ISO 14971: 2019
Risk Management
Verification
Design Inputs
Competent Authority
Stability Study
IVDR
User Requirements Specification (URS)
Instructions for Use
Scientific Validity
Requirements
Class B
Free!
ISO 13485: 2016
Clinical Performance
Regulatory Compliance
Class C
Validation
UDI
Design Transfer
EUDAMED
Safety
Quality by Design
Labeling
Notified Body
Shelf Life
Authorized Representative
Usability Engineering
Intended Purpose
Design Control
Analytical Performance