Electronic Medical Device Reporting (eMDR)
Learn key regulations required for electronic medical device reporting (EMDR)
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Electronic Medical Device Reporting (eMDR)
Effective medical device reporting is essential for ensuring patient safety and regulatory compliance. This course offers a detailed overview of electronic medical device reporting (eMDR), focusing on the key regulations that manufacturers must follow. It covers the essential steps for submitting reports electronically and highlights the importance of Good Documentation Practices (GDP) to ensure accuracy, traceability, and compliance. Participants will gain a clear understanding of the regulatory framework, the submission process, and why strict adherence to EMDR requirements is crucial for both patient safety and avoiding regulatory penalties. Through expert insights and practical guidance, this course provides the tools necessary to navigate EMDR effectively and maintain compliance in the medical device industry.
Learners will be able to:
- Define the key regulation requirements for electronic medical device reporting (eMDR)
- Know why the requirements for EMDR are important
- Submit reports to the EMDR system
- Know the eMDR standard requirements.
- Be prepared for electronic submission of your reports
- Optimize productivity and training time with flexible mobile learning using a desktop, laptop, tablet or mobile device.
- Fulfill new hire and annual FDA training requirements.
This online training is appropriate for individuals who are involved in the medical device sector of the life science industry.
Continuing Education Credit
PathWise is accredited by the International Association for Continuing Education and Training (IACET). PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.
Learners must complete the following in order to earn CEU credit:
- Verify your electronic signature
- Complete the full course module on ePath
- Complete the full instruction module
- Complete the post course assessment on ePath with an 80% score or better (learner will be given 2 opportunities to take the assessment).
Additional Online Modules
| WEB BASED TRAINING FOR COMPLIANCE | WEB BASED TRAINING FOR QUALITY SYSTEMS | WEB BASED TRAINING FOR PRODUCTIVITY |
|---|---|---|
| cGMP Training | Introduction to Investigations & CAPA | Effective Meeting Management |
| QSR | Introduction to Technical Writing | |
| Biologics | Introduction to Quality Change Control | |
| GDPGDP | Introduction to Human Factors and Performance Web Based Training | |
| Good Clinical Practices | Introduction to Quality Risk Management | |
| Combination Products | Inspection Readiness | |
| Electronic Records and Signatures | ||
| ISO 13485 | ||
| EU MDR 2017/745 |
Inquire about our corporate rates or Enterprise License, and get a demo of how our online learning works!
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