BIOE-225 Lecture Notes - Lecture 5: Quality Management System, Medical Device, Clinical Trial

• School: Lehigh University
• Department: Bio Engineering (BIOE)
• Course: BIOE-225
• Professor: Lori Herz

Document Summary

Lecture 5: medical devices safety and quality of marketed products. Medical devices quality system regulation: purpose: defines cgmp requirements for medical devices, definition of quality. (cid:862)totality of features a(cid:374)d characteristics that bear on the ability of a device to satisfy fitness-for-use, i(cid:374)cludi(cid:374)g safety a(cid:374)d perfor(cid:373)a(cid:374)ce(cid:863: outline: https://www. accessdata. fda. gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch. cfm?cfrpart=82. Subpart g production and process controls. Quality system requirements: 820. 20 management responsibility. Set and maintain adequate organizational structure and resources. Establish and maintain quality plans and procedures: 820. 25 personnel. Sufficient personnel with necessary background, training, and experience. Establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups: 820. 65 traceability. For devices for surgical implant, or to support or sustain life, and whose failure to perform can result in injury: establish and maintain procedures for identifying with a control number each unit, lot, or batch. Production and process controls: section 820. 70 production and process controls.