Navigating the 510(k), IDE and PMA Submission and Approval Process - Webinar By GlobalCompliancePanel 2012
22 Aug 2012
Webinar
Key Topics
The 510(k) -- Pre-market `notification` and FDA Device Clearance
Tougher Expectations / Requirements
Intended Use / Indications for Use
Predicates and Substantial Equivalence
Clinicals -- the `basics`
The IDE -- Investigational Device Exemption; IRB`s; Disclosures
Resolving a "Wrong" Decision
The PMA -- Pre-market Approval
Who should Attend
QA
Senior management in Devices and Combo Products
R&D
RA
Production
Engineering
Consultants
Operations
Past Events
Navigating the 510(k), IDE and PMA Submission and Approval Process - Webinar By GlobalCompliancePanel 2012 - 22 Aug 2012, Webinar (31102)
Navigating the 510(k), IDE and PMA Submission and Approval Process - Webinar By GlobalCompliancePanel 2026
Important
Please, check "Navigating the 510(k), IDE and PMA Submission and Approval Process - Webinar By GlobalCompliancePanel" official website for possible changes, before making any traveling arrangements
Event Categories
Education: Training
Health & Medicine: Healthcare, Medical device, Pharma
