This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).
Electronic reporting is also available to user facilities; however, the eMDR Final Rule permits user facilities to continue to submit only written reports to FDA. The requirements of this final rule will take effect on August 14, 2015.
This webinar will:
Provide an overview and answer questions related to FDA’s final rule requiring device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the FDA’s electronic format that FDA can process, review, and archive (hereinafter referred to as the eMDR Final Rule).
Provide general information regarding how to prepare and send an electronic postmarket medical device report to the Center for Devices and Radiological Health (CDRH) in FDA.
Help identify where you can find more detailed information on the preparation and transmission of the reports.
Review background on regulations pertaining to MDRs and who should or should not file via eMDR.
Why Should You Attend:
Being ready for the live eMDR is critical for your company. Mistakes in timing for submission, sending incorrect information and not being prepared to respond to an FDA inspector can cause a company needless time and money to correct issues.Electronic reporting is also available to user facilities; however, the eMDR Final Rule permits user facilities to continue to submit only written reports to FDA. The requirements of this final rule will take effect on August 14, 2015.
This webinar will:
Provide an overview and answer questions related to FDA’s final rule requiring device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the FDA’s electronic format that FDA can process, review, and archive (hereinafter referred to as the eMDR Final Rule).
Provide general information regarding how to prepare and send an electronic postmarket medical device report to the Center for Devices and Radiological Health (CDRH) in FDA.
Help identify where you can find more detailed information on the preparation and transmission of the reports.
Review background on regulations pertaining to MDRs and who should or should not file via eMDR.
Areas Covered in the Webinar:
- Basics of the Medical Device Reporting (MDR) Regulation
- Medical Device Reporting: Electronic Submission Requirements Final Rule
- Actions that Firms Have to Take Prior to Live Date
- Review the Basic Process for Preparing and Submitting Electronic Medical Device Reports (eMDRs)
- Best Practices for Your Firm Using eMDR
- Timing for Submission to eMDRs
- Which System Works Best for Your Firm?
- Readiness for FDA Inspector
Who Will Benefit:
- Complaint handling units
- Auditors
- Compliance officers
- Consultants/service providers
- Regulatory/legislative affairs professionals
- IT department supporting complaint handling
- Regulatory affairs reporting units
Course Provider
Rita Hoffman,
