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

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
• CIO/CFO/CTO
• 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.

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