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Principles of Medical Device Regulation Quiz

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Principles of Medical Device Regulation Quiz

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Questions and Answers

Which lecture is scheduled to be delivered by Daniel Gwinner?

Clinical Study Design
Production (correct)
Clinical Evaluation
Trial Statistics

When is the seminar on Computerized System Validation scheduled?

12.04.2023
28.06.2023 (correct)
26.04.2023
05.07.2023

Who is scheduled to deliver the lecture on Conformity Assessment?

No lecture on Conformity Assessment is scheduled.
Sinja Lagotzki (correct)
Melanie Fachet
Daniel Gwinner

Which topic is scheduled for the seminar on 14.06.2023?

Clinical Study Design (D) Signup and view all the answers

When is the lecture on Trial Statistics scheduled?

10.05.2023 (C) Signup and view all the answers

Which types of medical devices require clinical evaluation?

All classes require clinical evaluation (A) Signup and view all the answers

What are the three different routes for clinical evaluation of medical devices?

Scientific literature route, clinical investigation route, and combination route (B) Signup and view all the answers

What is the purpose of the scientific literature route in clinical evaluation?

To critically evaluate relevant scientific literature (A) Signup and view all the answers

Which route for clinical evaluation involves a combination of scientific literature and clinical investigation?

Combination route (A) Signup and view all the answers

What is the basis for clinical evaluation of medical devices?

Clinical data (D) Signup and view all the answers