Global Medical Device Laws and Regulations: US, EU, and Canada
June 18, 2013 - Palo Alto CA USComplianceOnline
referral@complianceonline.com
Phone:650-620-3915
Fax:650-963-2556
Areas Covered in the Webinar: Medical device laws and regulations in the US, EU and Canada. Definitions Regulatory framework for medical devices in the US, EU, and Canada Device classification Regulatory requirements for medical devices including in vitro diagnostic devices in the US, EU and Canada. Contents of a 510(k) and PMA in US Contents of a technical file and design dossier in EU Content of a medical device license application in Canada How to identify and meet the regulatory requirements. How to establish and maintain systematic methods to meet the regulatory requirements. How to streamline the regulatory process Instructor’s unique regulatory guide. Who will Benefit: Regulatory affairs (associates, specialists, managers, and directors) Clinical affairs (associates, specialists, coordinators, managers, directors and VPs) Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs) Research and development (associates, scientists, managers, directors and VPs) Product and development (associates, scientists, managers, directors and VPs) Marketing (associates, specialists, managers, directors and VPs) Site managers, and consultants Contract manufacturing organization (associates, scientists, managers, directors and VPs) Contract research organization (associates, scientists, managers, directors and VPs) Senior and executive management (VPs, SVPs, Presidents and CEOs) Contractors and subcontractors