Les Schnoll speaker of compliance global

01
Friday
January, 2016

Speaker: Les Schnoll
Duration: 90 Minutes
Product ID: 700039

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The Values and Benefits of Medical Device Reporting Compliance

Since the mid 1980s, the FDA has expressed concerns about their need to be informed of adverse events that may have been caused by or contributed to legally marketed medical devices.  As such, they promulgated the Medical Device Reporting regulation, 21 CFR 803, in 1984. The regulation requires reporting, within designated time periods, any death or serious injuries that may have been attributed to the devices, as well as any malfunctions of the device that could result in a death or serious injury. Failure to comply with the regulation results in the marketed device being misbranded.  So – are Medical Device Reporting regulations merely an additional bureaucratic regulation or do they add value and benefit to the manufacturer?

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Les Schnoll speaker of compliance global

18
Wednesday
March, 2015

Speaker: Les Schnoll
Duration: 90 Minutes
Product ID: 700018

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Supplier Quality Management: Streamline your Supply Chain

The FDA requires that manufacturers of medical devices have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. Having an effective Supplier Relationship Management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

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