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Webinar Medical Device Changes and the 510(k)

Event Details

Webinar Medical Device Changes and the 510(k)

Time: July 3, 2017 from 1pm to 2:30pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map:
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Mar 2, 2015

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Event Description

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"

Areas Covered in the Session :
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's current Guidance on 510(k) Device Modifications. This session will cover:
Deciding When to Submit a 510(k) for a Change to an Existing Device, K97-1
How to provide tools to document such decisions
It will discuss how companies can best document their decisions -- whether or not a new 510(k) filing is warranted
How to structure a decision matrix to document change decisions
How to evaluate changes that could trigger the "Tipping Point"
Who makes the decisions and how to defend them
How to implement formal methods with documented, and defensible rationale
Preparing for further 510(k) changes in the future
Who Will Benefit:
This webinar is a must for companies in the Medical Device and combination products fields. The employees who will benefit include:
Research & Development
Engineering Staff
Quality Assurance
Regulatory Affairs
Lean & Six Sigma staff
New Product Development
Mid-level and Senior Management
Project Leaders
Price tags:
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
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 :
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