All medical device companies are required to electronically submit their adverse event Medwatch Form 3500A to FDA by August 14.

All medical device companies are required to electronically submit their adverse event Medwatch Form 3500A to FDA by August 14.

According to FDA’s 21 CFR Part 803 Electronic Reporting for Medical Device Adverse Event Reporting (eMDR), all medical device companies are required to electronically submit their adverse event Medwatch Form 3500A to FDA.

August 14, 2015 deadline
The mandate to transition over to all electronic submissions is August 14, 2015.  No other method of submission will be accepted beyond that date.

Webinar description
Although FDA provides an eSubmitter tool for submissions, it does not integrate with your quality management system, and requires inefficient manual input and management. This complimentary webinar will provide you with valuable insights to implement or improve your electronic solution for submitting your adverse event reports. 

Review Webinar
Review recording of July 23, 2015 webinar by going to
http://go.assurx.com/emdr-webinar-request

Speaker information
Jeff Mazik, Vice President, Life Science Solutions for AssurX, Inc. will be presenting. Jeff previously served as IT Head, Manufacturing & Engineering Systems for Alcon (a Division of Novartis). Jeff worked at Alcon for 15 years, and was responsible for the global rollout and support of many varied global software systems in the areas of Quality Management, Engineering, Manufacturing, Corporate, and Safety/Security/Environmental Affairs.

About AssurX, Inc.
AssurX, Inc. provides global companies with enterprise quality management systems and regulatory compliance software solutions. AssurX’s flexible, all-in-one system automates quality and compliance related processes so issues can be centrally managed—from detection to corrective action and trend analysis. It helps collect, organize, analyze and share information to better manage risk and improve quality and compliance performance everywhere in the enterprise.

For the latest industry insights and updates go to http://blog.assurx.com