Medical Device Regulation for Your Protection

How do you know if the medical device you may be using was manufactured according to established quality procedures? Who is watching out for the consumer to make sure such items are manufactured according to established quality standards? We may never think about these issues during a medical emergency or simply when receiving routine medical care, but extensive planning is required for the development and manufacturing of medical devices and pharmaceutical products to ensure our protection.

As you know, the U.S. Food and Drug Administration (FDA) is responsible for the regulation of drugs, medical devices, food, biologics and radiation-emitting devices, and has accountability for setting such standards and enforcing compliance. So if you are a medical device manufacturer, or represent such businesses for their risk management needs, we’ve authored a whitepaper on this topic. Titled “FDA – QSR; Regulation for your Medical Protection,.  It can be found on our dedicated Technology insurance website:

This paper was authored by OneBeacon Technology’s Risk Control Specialist Richard Triplett, who has over 30 years of loss control experience. His specialty insurance focus has included information technology and medical technology. He has been with OneBeacon for the past eight years and is yet another example of OneBeacon expertise.

Again, to download this whitepaper, click here. Let us know if you have any ideas for other technology risk management  whitepapers!

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