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USMLE® Step 1 flashcards

Medical Devices Manufacturing Practices

This class was created by Brainscape user Adrian Soh. Visit their profile to learn more about the creator.

By: Adrian Soh
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Decks in this class (7)

Week 1 - topic 1a (medical devices classification
Define the term medical devices,
Name the difference between medic...,
Name the difference between medic...
20  cards
Week 2 - Topic 1b (Risk classification for MDs)
Medical devices risk is classifie...,
What are the main areas to regula...,
Define device failures
28  cards
Week 3 - Medical device standards part 1
What is the definition of essenti...,
What do the essential principles ...,
Some side notes
30  cards
Week 5 medical device standards part 2
Describe the medical device manuf...,
Why must the manufacturing sector...,
What is a quality management system
16  cards
Week 6 : Manufacturing Standards Focus ISO13485 and GDP
What does the element of conformi...,
What is under quality management ...,
What is under device safety perfo...
16  cards
Week 7 : Medical Device Design and Development and Product Realization Process [clutch moment]
What is the design control process,
Describe design and development p...,
Describe design input
10  cards
Week 8 : Medical Device Industry Regulatory Scope for Safety, Quality and Performance [Clutch Moment]
What is the main consideration fo...,
Describe medical post market surv...,
What is under post market surveil...
8  cards

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Medical Devices Manufacturing Practices

  • Class purpose General learning

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