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


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

  • Duration: 90 Min
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.
Last Recorded Date: Jun-2013


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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:

  • Overview And Timeline Of Medical Device Reporting(MDR) at US FDA
  • Requirements for Individual Adverse Event Reports
  • User Facility Reporting Requirements
  • Importer Reporting Requirements
  • Manufacturer Reporting Requirements
  • MedWatch voluntary reporting & MedWatcher mobile app
  • Event Codes for MDRs
  • Manufacturer and User Facility Device Experience Database(MAUDE)
  • Strengthening medical device postmarket surveillance , UDI (2012 report-FDA)
  • Future Of Medical Device Reporting In The Biomedical Field Globally

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.

  • Manufacturers of Medical Devices (Industry)
  • User Facilities of Medical Devices(Hospitals, Clinics)
  • Importers, Customs & Border professionals
  • Medical Device distributors
  • Consumers, Patients
  • Compliance Officers
  • Health Information Managers
  • Legal Counsel, Regulatory affairs
  • Data and Device Standards experts
  • Audit/Inspection coordinators, internal auditors
  • QA / QC managers, executives and personnel
  • IT / IS managers and personnel
  • Entrepreneurs (Devices, Surveillance, Informatics)
  • Consultants and Strategists

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:

  • Advisor and participant (ONC/DHHS for Health IT, Standards & Interoperability Framework, Meaningful Use Stages/EHR, Federal Health Architecture, Health Information Exchanges-HIMSS, Health Level 7/ISO TC215 standards).
  • Executive director of Global Bio Health Tech Center and senior policy advisor at CAL2CAL group of companies
  • Medical Devices Committee Member, Author at The Food and Drug Law Institute,

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

  • In academia (Johns Hopkins, University of Virginia, EU), researched concerning biomedical applications and bio-chem-informatics.
  • In industry (FannieMae, Sysco/Sentrana, MakronanoKosmos, Cal2Cal) designed innovative decision systems, managed analytics projects, cofounded eHealth business, consulted business development, provided policy analysis.
  • In government (US-FDA/DHHS), trained and worked in regulatory science, enterprise architecture, standards, and policy in public health and health IT. Served as Program Manager, for Maryland BioTechnology Center, Business and Economic Development.
Follow us :



Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2021 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method