Loading Purplepass...
When to Submit a 510(k) for a Change to an Existing Device
Tuesday, August 14th at 9:00am PST
Online sale ends: 08/14/18 at 8:00am PST
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Fremont, CA 94539
-= series =-
Buy Tickets
Buy Tickets
This presentation, will aid manufacturers of medical devices who 

intend to modify a 510(k)-cleared device or a preamendments 

device subject to 510(k)

Why should you Attend:
This presentation uses the latest FDA thinking and guidance 

documents to assist the manufacturers in enhancing the 

predictability, consistency, and transparency of the "when to 

submit" decision-making process by providing a least burdensome 

approach, and describing in greater detail the regulatory 

framework, policies, and practices underlying such a decision.

Areas Covered in the Session:
The main types of changes that might be made to a device: When 

a manufacturer modifies their device with the intent to 

significantly affect the safety and effectiveness of a device (for 

example to significantly improve clinical outcome or to mitigate a 

known risk) submission of a new 510(k) is likely.

Who Will Benefit:
Quality Managers
Quality Engineers
Regulatory Affairs
Small Business Owners

Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She 

has degrees in Microbiology and Computing and 40 years of 

experience in the Life Sciences, Healthcare & Public Health 

Services. Experience combines Quality Assurance, Regulatory 

Compliance, Business Administration, Information Technology, 

Project Management, Clinical Lab Science, Microbiology, Food 

Safety & Turnarounds.

Event Fee: One Dial-in One Attendee Price: US $290.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Presented By

9:00am to 12:00pm
Doors open at 12:00am

General Admission: $290.00

All Ages

Online<br> 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA<br> Fremont, 94539


Wednesday, June 13th

Past Event
Tuesday, June 12th

Past Event
Tuesday, June 12th

Past Event