Medical Device Reporting for Manufacturers, Importers and Medical Device User Facilities
June 4, 2013 - Palo Alto CA USComplianceOnline
referral@complianceonline.com
Phone:650-620-3915
Fax:650-963-2556
Areas Covered in the Webinar: Overview And Timeline Of Medical Device Reporting(MDR) at US FDA Requirements for Individual Adverse Event Reports User Facility Reporting Requirements Importer Reporting Requirements Manufacturer Reporting Requirements MedWatch voluntary reporting & MedWatcher mobile app Event Codes for MDRs Manufacturer and User Facility Device Experience Database(MAUDE) Strengthening medical device postmarket surveillance , UDI (2012 report-FDA) Future Of Medical Device Reporting In The Biomedical Field Globally Who will benefit: All industries, groups, managers and professionals who have responsibility or need to understand the fundamentals and more details of MDRs should attend. Manufacturers of Medical Devices (Industry) User Facilities of Medical Devices(Hospitals, Clinics) Importers, Customs & Border professionals Medical Device distributors Consumers, Patients Compliance Officers Health Information Managers Legal Counsel, Regulatory affairs Data and Device Standards experts CIO/CFO/CTO Audit/Inspection coordinators, internal auditors QA / QC managers, executives and personnel IT / IS managers and personnel Entrepreneurs (Devices, Surveillance, Informatics) Consultants and Strategists