Quality Systems ((3 Units))

Catalog description

Prerequisite: Admission to the Medical Device Management and Regulation certificate program or BMEN 391 . Standards ISO 13485 and 14971, Code of Federal Regulations Title 21; quality management system (QMS); elements of auditing including Change Controls, Good Documentation, Nonconformances, Supplier Controls, Receiving Controls, Corrective Action and Preventive Action (CAPA); Sampling.