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Medical Device Reporting for Manufacturers, Importers and Medical Device User Facilities

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This webinar on Medical Device Reporting (MDR) will cover FDA requirements for importers, manufacturers and hospitals to report medical device adverse events. It will discuss current policies and guidances for Medical Device Reporting and provide update on upcoming regulations.

Instructor: Kosta Makrodimitris
Product ID: 702958
Training Level: Intermediate

Why Should you Attend:

The MDR regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report medical device adverse events.

This 90-minute webinar will explain the current policies and guidances (1984-current, FDAMA and amendments), provide update on upcoming regulations and discuss what industry, hospitals and patients should know and how to conform to MDR rules. This course will explain the requirements for all these roles in the industry who need to conform with the regulations and the standard process. In addition, the course will describe the voluntary reporting mechanism and tools (MedWatch) for hospitals and consumers. Finally, we will explain further the FDA Event codes for MDRs and the Manufacturer and User Facility Device Experience Database.

The presentation will also explore relevant MDR initiatives and standards in the U.S. and will present an overview of the global regulations and cases in the field. There is a recent report that FDA published on strengthening the medical device post-market surveillance and Unique Device Identification (UDI) plans that will affect the industry in the coming years. This report will be reviewed too.

Areas Covered in the Webinar:

Who will benefit:

All industries, groups, managers and professionals who have responsibility or need to understand the fundamentals and more details of MDRs should attend.

Instructor Profile:

Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Informatics Advisor, Author & Strategist.

He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (medical devices, foods, drugs, personalized medicine, health IT). He is involved as:

Dr. Makrodimitris combines a multidisciplinary background and accomplishments in Health IT/Informatics, Policy, Standards and Innovation

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Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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Training Options Training Duration = 90 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$499.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days