• New FDA Draft Guidance on 510(k) Program

• Right Brains and Left Brains – Can They Work Together?

  Good processes need not stifle the input and output of contributors, they enable both Right Brains and Left Brains to do their best work.

• To cloud or not to cloud – FDA’s Part 11 implications

• What’s your (underlying) problem?

  A core value at StarFish is to solve the right problem. How we dig deeper to understand “What’s your (underlying) problem?”.

• Qualifying a development partner

  When qualifying a Development Partner the greatest risk is in the less apparent, harder to discern, ‘soft side’ of the business.

• Boreal Testimonial

• A New Beginning

  Exploring a new design idea should be like leaving behind the preconceived notions of what something should be.

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  Field programmable gate arrays (FPGA)

  Consider using a field programmable gate array FPGA to augment or even replace the processor for tasks too intense or frequent.

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  Margin Matters

  As part of any initial medical device product definition always consider the margin in medical device development discussions.

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