Why is Biocompatibility Testing of Medical Devices Critical?

Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals. An upcoming series of seminars, organized by UL, will discu…

Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals. An upcoming series of seminars, organized by UL, will discu…

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How is Industry Dealing with Tax – Survey Results Tell Story

The U.S. Medical Device Excise Tax continues to draw scorn from industry advocates as a jobs killer. However, new data from a survey tells a different story about how executives are compensating for costs of the tax, and that story varies considerably by size of company.

The U.S. Medical Device Excise Tax continues to draw scorn from industry advocates as a jobs killer. However, new data from a survey tells a different story about how executives are compensating for costs of the tax, and that story varies considerably by size of company.

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FDA’s Single Audit Program Invites Participants

The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.

The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.

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J&J Device Sales Fall

The healthcare giant reported worldwide medical devices sales of $27.5 billion for the full-year 2014, a decrease of 3.4 percent versus the prior year.

The healthcare giant reported worldwide medical devices sales of $27.5 billion for the full-year 2014, a decrease of 3.4 percent versus the prior year.

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Behemoth Merger by End of the Month?

According to a regulatory filing dated January 12, Medtronic and Covidien could complete their $43 billion mega-merger by the end of the month.

According to a regulatory filing dated January 12, Medtronic and Covidien could complete their $43 billion mega-merger by the end of the month.

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Apps: Fun or Medical Devices?

Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.

Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.

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