While the August 2015 reporting deadline for eMDR submissions has passed, many quality professionals continue to struggle with the complex implementation and maintenance of an individual eSubmitter and Electronic Submission Gateway (ESG) account. The FDA stated that the electronic submission process will accelerate reporting procedures and decrease the burden of data entry; however, manufacturers have encountered significant burdens and road blocks simply trying to implement the reporting programs on their operating systems. As medical device quality teams continue to collect and report product complaints and adverse events, they must also explore options for implementing a reliable and accurate eMDR system.
- eMDR decisions and first steps
- Navigating the ESG Account Setup
- CeSub eSubmitter and ESG error and issue management
- Technical tips for eMDR quality teams
Diane Sheffer, CISA, RAC
Senior Manager, Regulatory Affairs