Question

From a pre-clinical viewpoint, which of the following constitute pre-clinical activities in medical device development?

A) Animal use testing to validate the design of your device
B) Bench testing to verify that your design performs as designed
C) Biocompatibility/Toxicity testing
D) Functional/Safety/Performance testing
E) All of the above

Answer 1

Pre-clinical activities in medical device development include animal use testing, bench testing, biocompatibility/toxicity testing, and functional/safety/performance testing. These activities are part of ensuring the device's design, safety, and efficacy before clinical trials.

Step-by-step explanation:

From a pre-clinical viewpoint, all of the following constitute pre-clinical activities in medical device development:

• Animal use testing to validate the design of your device
• Bench testing to verify that your design performs as designed
• Biocompatibility/Toxicity testing
• Functional/Safety/Performance testing

Pre-clinical activities are critical for assessing the safety and efficacy of a medical device before it proceeds to clinical trials. They include a combination of in vitro and in vivo studies, such as bench testing and animal use testing, to validate a device's design, functionality, and potential biological risks. This phase serves to identify any design flaws or risks to patient safety and can include testing for biocompatibility, toxicity, and overall device performance under simulated conditions.