Ccourse introduces the concepts needed to understand, develop, and implement a quality management system as outlined in the medical devices standard ISO 13485:2003. This course also discusses the use of ISO 14971:2007, which contains key principles and guidance for risk management. PD CEN ISO/TR 14969:2005, “Medical devices – quality management systems – guidance on the application of ISO 13485:2003” will also be used as a learning tool. Experienced instructors explain how to integrate ISO 13485:2003 system implementation with the overall business, prepare for audits, and achieve ISO 13485:2003 registration. Exercises prepare students to identify key requirements, create documentation, develop project plans, and prepare a scope map. (1.6 CEUs)
08SI25000 Sep 18 – 19 (Th-F, 8am–5:30pm)
$995
Continuing Education Center | 1100 South Marietta Parkway, Building #WE | Marietta, GA | 30060 | 678-915-7240