The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 4, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Court
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Dec 12, 2014
On Going Christmas Offers: Offer valid till 1 st January 2015
1. Register an attendee for Single Live:
Get 10% of on every Registration
First 10 attendees will receive recording Access to the webinar for No Additional Cost
For Coupon Code call customer support: 416-915-4458
2. Register your Group for Corporate Live:
Get 15% of on every Registration
Every group registrant will receive Recording Access to the webinar for No Additional Cost
For Coupon Code call customer support: 416-915-4458
3. Unlimited viewing for 4 days
4. The discounted amount will appear after entering the Coupon Code in the Secure Check Out Page
Description :
This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission.
This webinar is intended to discuss how to put together a pre-submission (Q-submission) to obtain FDA feedback on your proposed questions, which will be helpful and useful for your device design, preclinical and clinical study plan and design, if applicable.
Areas Covered in the Session :
Statute(s) And Regulations
Definitions
Device Classification And Predicates
510(k) Program
When 510(k)s Are Required
Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
Substantial Equivalence: Factors to Consider and Special Considerations
Addressing e-Copy And RTA Policy Requirements
Applicable Standards and Guidance
510(k) Contents And Format
Common Pitfalls and How to Prevent Them
What to Ensure While Preparing Your Q-Submission and a 510(k) Application
Responding to FDA's Request of Additional Information.
Resolving Different Opinions and Interpretations
Best Practices for a Q-submission
Best Practices for a 510(k) Preparation, Submission and Clearance
Speaker's Practical, Actionable and Sustainable Solutions
Conclusions
Who Will Benefit:
Regulatory Affairs
Research & Development
Quality Assurance
Quality Control
Quality System Management
CROs
Consultants
Contractors/Subcontractors
Senior management
Anyone interested in 510(k) matters
Price tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1358
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