Event Detail
Implementing Design control for Medical Devices and IVDs
February 19, 2013 - san francisco CA US
online compliance panel
onlinecompliancepanel1@gmail.com
Phone: 15108575896
Fax: +1-510-509-9659
Description: Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs. Objectives of the Presentation: Federal Statutes and Regulations Governing Medical Devices in the US Introduction and Definitions Design and Development Planning Design Input Design Output Design Review Design Verification And Validation including Software Validation Design Transfer Design Changes Design History File (DHF) Device History Record (DHR) Device Master Record (DMR) Who can Benefit: R&D Scientists, Engineers, Managers, and Directors Regulatory Affairs Quality Professionals Product Development Professionals CROs Consultants Senior Management Contractors and Subcontractors Anyone interested in the subject Pricing Live Session for one participant Price: $243.00 Corporate Live Session 4 to 10 participants in single location. Price:$986.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $288.00