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  Proposed EU Medical Device Regulations (2012)

  Proposed EU Medical Device Regulations (2012) replace current Directives with two Regulations; one for medical devices and the other for IVDD

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  Rushing to the Wrong Product (implementation)

  Insufficient testing and premature optimization can lead to a rush to the wrong medical device in the product definition phase.

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  US Medical Device Tax- Good or bad for the industry?

  Article with update links on 2012 US Medical Device Tax in the US and blogs with controversial views of the tax impact on the industry.

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  Medical Device Design Control, the Method to the Madness

  Design control shouldn’t inhibit creativity; it should enable it by providing a safety net when the unknowns start showing up during design. 

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  Risk Management as a Design Tool in Medical Device Development

  How do we define the quality of a medical device? What attributes cause us to come to the conclusion that a device…

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  5 Common Ways to Get Your Medical Device Product Wrong

  Common Clinical Input, Financial Model, Critical Requirements, Regulatory. Prototyping mistakes that can get a Medical Device Product Wrong.

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  Recommended FDA report: Understanding Barriers to Medical Device Quality

  FDA report entitled “Understanding Barriers to Medical Device Quality” examines  the current quality status of medical devices.

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  Christie Consulting Services Testimonial: Developing medical devices with StarFish Medical

  Christie Consulting Services Testimonial "I would recommend StarFish to anybody in the medical device industry who needs a strong development partner."

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