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.
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
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. 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).
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