Medical Device Reporting (FDA) for Manufacturers, Importers and User Facilities

Event Information
Product Format
Prerecorded Event
Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR
60 Minutes
Product Description

Understand the MDR Rules Regulated by FDA with Dr. Makrodimitris

Device reporting was enacted by Congress to increase the information FDA and manufacturers receive about problems with medical devices although manufacturers and importers of medical devices have been required since 1984 to report issues. Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report issues, injuries and deaths to FDA and manufacturers.

Let our expert presenter Dr Kosta Makrodimitris help you understand the Medical Device Reporting (MDR) and what are the FDA requirements for importers, manufacturers, hospitals and consumers. This power packed webinar will provide the current and expected policies for Medical Device Reporting (MDR) in US.. The MDR regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report medical device adverse events.

Our expert will explain what are the current policies and guidances (1984-current, FDAMA), update on upcoming regulations and discuss what industry, hospitals and patients should know and how to conform to MDR rules.

Relevant MDR initiatives and standards in US will be explored and the audio conference will present an overview of the global regulations and cases in the field. Here are the tools you’ll walk away with:

  • Reference documents
  • Policies and Guidances
  • Tips for MDRs

Here are few topics covered in the session:

  • 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
  • Event codes for MDRs
  • MedWatch voluntary reporting & MedWatcher mobile app
  • 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 should attend?

  • Manufacturers of Medical Devices (Industry)
  • User Facilities of Medical Devices(Hospitals, Clinics)
  • Importers, Customs & Border professionals
  • Medical Device distributor
  • 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


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About Our Speaker

Dr. Kosta Makrodimitris

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...   More Info
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