Medical Device Reporting (MDR) - By Compliance Global Inc

NEW HYDE PARK, N.Y. - Aug. 4, 2015 - PRLog -- Overview

Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccur. The Medical Device Reporting (MDR) regulation (21 CRF 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their components that are used to produce or assemble the final device may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur.

Why Should You Attend

The FDA expects health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality, and therapeutic failures. The overall intent of this webinar, just like FAA for passenger safety is to provide critical information that helps improve patient safety.

Learning Objectives

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the post market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of medical devices.

Device Manufacturers are required to submit certain types of reports for adverse events and product problems to the FDA in a very short time about identified problems with a medical device. If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because  the FDA requested reports in accordance with 803.53(b)

Who Will Benefit

•  Quality Assurance (QA) Professionals
•  Operations Management Professionals
•  Medical Device distributors
•  Consumers, Patients
•  Compliance Officers
•  Health Information Managers
•  Legal Counsel
•  Data and Device Standards experts
•  CIO/CFO/CTO
•  Audit/Inspection coordinators, internal auditors
•  IT / IS managers and personnel
•  Consultants and Strategists

For more information, please visit https://www.complianceglobal.us/product/700166

About Compliance Global Inc:

Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.

Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.

Email: referrals@complianceglobal.us

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Tel: +1-516-900-5515