2016 - Webinar on FDA’s New eMDR Requirements

Firms need to reassess their MDR procedures for information accuracy and coding. Efficiency is equally important. MDR requires the prompt management of “risk to health” information. Such information is critical to the medical device postmarket program and equally loaded as an enforcement issue for failures to meet eMDR requirements. Firms no longer have the option of being on a learning curve. Firms need to be sure that their related postmarket programs are well coordinated with eMDR requirements. Otherwise, they will be facing a tough Q.A. problem.
Areas Covered in the Session :
? MDRs reporting elements for
o Manufacturers
o Importers
o User facilities
? New eMDR program requirements
o eSubmitter program
o HL7 electronic submissions
o Electronic Submissions Gateway (ESG) account
o Operational deadlines
o eMDR rejections
? Revisions to related postmarket programs
o Quality Assurance coverage
o Training
o Corrective and Preventive Actions
? Enforcement
Who Will Benefit:
? Device manufacturers
? Device importers
? User facilities
? FDA consultants
? Domestic and international regulatory affairs managers
? Q.A. managers / training
? Complaint and MDR managers
? Data processing managers
? 3rd party complaint managers