San Francisco Bay Area


Welcome to the SOCRA San Francisco Bay Area Chapter page. Information for the latest meeting is below. If you have any questions, please reach out to the Chapter Chairperson or the SOCRA office at office@socra.org.


 SOCRA San Francisco Bay Area Chapter Meeting Announcement

 The SF Bay Area Chapter presents

“Post-Market Regulatory Affairs for Medical Devices : A Comprehensive Overview”

 

Date: September, 25th, 2024

Time: 11:00 am – 12:00 PM (Pacific Time)

Location: Virtual Attendance only 

Speaker:  

Swapnali Bansode, M.S. (Regulatory Affairs)

Senior Regulatory Affairs Specialist

Medtronic

As a Senior Regulatory Affairs Specialist at Medtronic, Swapnali, dedicated to bringing innovative medical devices to patients in need and positively impacting human health. With over fourteen years of professional experience in regulatory affairs. Supported over 120 global regulated markets to obtain new licenses and renewals for Class III devices and authored FDA and  EU MDR technical files product submissions. She is committed to professional growth and her ability to inspire and guide others have been key to her success in regulatory affairs.

 

Objectives:

  1. Medical Device Risk Classification
  2. Post-Market Regulatory Activities for FDA Compliance
  3. Managing Medical Devices in Global Markets: EU and Rest of the World (ROW)

 

NOTE:  Remote site agreements are NOT required for this chapter meeting.

Details to enable virtual attendance will be sent to all attendees who have RSVP'd.

 

SOCRA CEUs available: One CEU for SOCRA Members & Only SOCRA members receive a certificate of attendance

 

COST:   FREE admission (members and nonmembers are welcome)

 

Please register at 

https://smccd.zoom.us/j/81254085687?pwd=1gKStNM2AmY7ChmzGb2wJyyNbMX5iI.1

 

On registering, you will receive a confirmation email containing information about joining the meeting.

 

Questions: Please contact: socrabayareachapter@gmail.com

 

 

Chapter Chair:

Archana Narasanna, CCRP

Narasanna@gmail.com

socrabayareachapter@gmail.com

Email