Clinical Trials and Regulations

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

Decks in this class (16)

Lecture 1: Design Control
Design control planning stages
1  cards
Lecture 2: Medical Device Regulations
Regulatory body and associates,
What are the 3 statutory committe...,
What is a standard
12  cards
Lecture 3: Medical Device Classification
Why was argmd developed,
Scope of argmd,
Elements of medical device regula...
12  cards
Lecture 4: Device Standards
Standard definition,
Class i equipment,
Class ii equipment
4  cards
Lecture 5: Medical Device Standards
As nzs 3000,
As nzs 3003,
As nzs 3100
7  cards
Lecture 6: Technical Management Standard
Sections of 3551,
Section 1,
Section 2
6  cards
Lecture 7: Electrical Circuits
Explain australias electrical sup...
1  cards
Lecture 8: Electrical Patient Circuits
Describe a signal circuit,
Describe the anatomy of the heart,
Where are electrodes placed to fo...
4  cards
Lecture 9: Electrical Safety Testing
Functional earth,
Protective earthing,
Equipotential earthing
4  cards
Lecture 10: Mechanical Circuits
Describe the similarities between...,
Draw the pneumatic patient circui...,
Risks of cct prevented
7  cards
Lecture 11: Mechanical Patient Circuits
Opposing forces to airway driving...,
Draw dynamic pv curves,
Describe flow tvol paw and poes f...
16  cards
Lecture 12: Supply of Unapproved Therapeutic Goods
Control of supply of therapeutic ...,
Ways to get devices not on artg,
Clinical trials definition
6  cards
Lecture 13: Clinical Trials
Requirements for starting a clini...,
Phase i,
Phase ii
10  cards
Lecture 14: Good Clinical Practice
Principles of codes of good clini...,
List a few responsibilities of in...,
List a few responsibilities of sp...
4  cards
Scopes
As nzs 2500,
As nzs 3000,
As nzs 3551
5  cards
Final Exam
Waterfall design process,
Regulatory bodiesstatutory comittees,
Medical device definition
31  cards

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Clinical Trials and Regulations

  • Class purpose General learning

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