Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission 2015
02 Jul 2015
Online Event
Description
Topics
Definitions
Laws and Regulations
510(k) Program
Device Classification and Predicates
Applicable Regulatory Requirements
When are 510(k)s Required
510(k) Requirements, Contents and Format
Q-Submission and How to Effectively Use It
Addressing e-Copy and RTA Policy Requirements
Substantial Equivalence: Factors to Consider and Special Considerations
Common Mistakes and How to Prevent Them
Applicable Standards and Guidance
Responding to FDA’s Request of Additional Information
De Novo Process Pursuant to FDASIA 2012
Best Practices for a Q-submission; 510(k) Preparation, Submission and Clearance
Resolving Different Opinions and Interpretations
Conclusions
Speaker’s Practical, Actionable and Sustainable Solutions
Who should Attend
R&D
RA
CROs
QA/QC/QS
Contractors/subcontractors
Consultants
Anyone interested in 510(k) matters
Senior management
Past Events
Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission 2015 - 02 Jul 2015, Online Event (51368)
Important
Please, check "Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission" official website for possible changes, before making any traveling arrangements
