BIOE-225 Lecture Notes - Lecture 4: Medical Device, Quality Assurance, Risk Assessment
4 Nov 2018
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Medical device: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body. Medical device classification: potentially pose a significant risk of illness or injury to patient, requires pre-market approval (pma) before device can be sold. Includes the submission of clinical data to support claims made for the device: class iii, class ii, moderate risk to patient, requires pre-market notification 510(k), or just known as 510(k) Less comprehensive than pma: class i, u(cid:271)je(cid:272)ted to (cid:862)ge(cid:374)e(cid:396)al (cid:272)o(cid:374)t(cid:396)ols(cid:863), (cid:449)hi(cid:272)h apply to all de(cid:448)i(cid:272)es to e(cid:374)su(cid:396)e safety and.
