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  Errata – or – That’s Just Plain Codswallop!

  When designing medical devices, use trustworthy data sources! Reading the manufacturer’s spec sheets and errata is not sufficient for problem-free design.

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  FDA Recognized Standards List Number 30 for Medical Devices

  Updated FDA Recognized Standards for use in premarket reviews of medical devices with declaration of conformity to consensus standards.

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  Medical Device Internal Auditing – Making Friends with “Bad News”

  Medical Device Internal Auditing is vital in device development, but the results of an internal audit are not always easy to hear.

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  Squeeze Insurance in Medical Device Development

  The game seems to be stacked against innovative entrepreneurs in the medical device space. Squeeze insurance turns the odds in your favour.

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  Extreme Risk Management in Medical Device Development

  Enjoy a smooth product development ride by apply an extreme risk management approach for device, manufacturing and project.

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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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