Lecture 3 –
The Regulation of Medical Device Design
product = all the documentation needed!
what does the FDA really expect?
o they are not scientists and engineers!
the responsibility and expertise lies with the manufacturer
BME 402 Notes
• neocortex = layer that surrounds the brain
• Turret’s Syndrome = everything you think of just comes out ~> associated with the basal
• thalamus = relays sensory information to various parts of the brain
do dogs have empathy too?
SENSORY, SOMATOSENSORY AND TOUCH
(read ch. 22-24)
sensing vs. perceiving
o measuring a kind of physical “energy” (e.g., light levels/patterns across an array,
sound levels/pressure) objectively
o vision = measuri