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FDA Medical Device Reporting (MDR)

NSF International, Pharmaceutical Services
Course summary
1.5 hours
299 USD
English
Distance
Next available date: Enquire for more information - Distance
e-learning / Online / Distance

Course description

FDA Medical Device Reporting (MDR)

Medical Device Reporting is part of the Code of Federal Regulations - 21 CFR Part 803, mandated by Congress in 21 U.S.C. in 1976 to provide for federal oversight of medical devices. It establishes the reporting requirements for not only manufacturers, but also importers and user facilities and is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving marketed medical devices. It also helps to identify device problems that may be occurring across manufacturers and assists with trending analyses. Medical Device Reporting provides a method for user facilities to inform FDA and the manufacturer about problems they are seeing and experiencing. Medical Device Reporting is managed by the Center for Devices and Radiological Health (CDRH) at FDA. Other parts of the CFR interact with this portion of the regulation, including Part 806 - Corrections and Removals and part 820 - Good Manufacturing Practices.

Outcome / Qualification etc.

Certificate

By completing/passing this course, you will attain the certificate Medical Device Certificate

Expenses

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

About provider

pharma training courses

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...


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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York

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