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  Managing Expectations in Medical Device Development

  How to manage medical device development expectations to keep development team, investors, and funding agencies all on the same page.

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  Embracing Failure in the Medical Device Industry

  Embracing Failure means exploring the value in ‘failing fast’ and acknowledging failures and their causes in medical device development.

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  Can Innovators Implement?

  Can you do innovative medical device product development without the right complement of innovators and implementors?

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  Diversity & Innovation, Problem Solving Methodologies in Medical Device Design

  Diversity & Innovation in the team dynamics of a medical device design team are an essential part of the development process.

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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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