How to identify and assess the regulatory requirements
The recent changes in the 510(k) program and guidance documents relating to both 510(k)s and PMAs
How to increase a 510(k) and PMA submission quality
How to meet the regulatory requirements in a systematic, integrative manner
How to format succinct and comprehensive 510(k) and PMA submissions
Who should Attend
Anyone in the FDA-regulated industry including, medical device, drugs, biologics, in vitro diagnostic devices or any combination products :
Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
Regulatory affairs (associates, specialists, managers, and directors)
Research and development (associates, scientists, managers, directors and VPs)
Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
Marketing (associates, specialists, managers, directors and VPs)
Product and development (associates, scientists, managers, directors and VPs)
Contract manufacturing organization (associates, scientists, managers, directors and VPs)
Site managers, and consultants
Senior and executive management (VPs, SVPs, Presidents and CEOs)
Contract research organization (associates, scientists, managers, directors and VPs)
Contractors and subcontractors
Past Events
How to Format Succinct and Comprehensive 510(k)s and PMAs 2012 - 26-27 Apr 2012, Hilton Boston Park Plaza, Massachusetts, United States (28096)
How to Format a Succinct and Comprehensive 510(k) Submission 2012 - 17 Jan 2012, Webinar (22088)
How to Format Succinct and Comprehensive 510(k)s and PMAs 2026
Important
Please, check "How to Format Succinct and Comprehensive 510(k)s and PMAs" official website for possible changes, before making any traveling arrangements
