Export Certificate for Medical Devices and Types of Certificates

Overview:

In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries. To this end, certain countries require an Export Certificate that the manufacturer and its devices are indeed in compliance with FDA regulations.

Areas Covered in the Session:

• Purpose of Presentation
• Background
• Use of export certificates
• Types of Certificates (including Export permit)
• How to choose a certificate type
• How to request Processing
• Record keeping
• CDRH Export Certification and Tracking System (CECATS)

Who Will Benefit:

• Clinical Trial Physician / Doctor
• Manager to Senior Director of
• Regulatory Affairs
• Quality Assurance
• Clinical Research
• Data Management
• Data Monitoring
• Institutional Review Board

Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.