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  3 real–world approaches to an FDA inspection

  FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing.

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  IEC 62366-1:2015 vs Applying Human Factors and Usability Engineering

  Exploration of applying IEC-62366-1:2015 or human factors engineering to the design of medical devices compared to the FDA guidance document.

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  FDA’s Premarket Evaluation Team “hit list” for human factors guidance

  Did you know that this year FDA’s Human Factors Premarket Evaluation Team have a priority review hit-list for medical devices?

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  Is the MAUDE database part of your development or due diligence process?

  Engineers, regulatory advisors, and patent filing teams should review the MAUDE database as part of development and due diligence process.

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  9 ways Project Managers make or break Medical Device development

  9 ways a Medical Device development project project manager (PM) is critical for medical device development, and manufacture. 

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  Mapping Your Project Course – 5 Areas that focus Early Requirements Definition

  Ways to hone focus, and help ensure early requirements definitions are well formed to solve the right problems in medical device projects.

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  Use standard methods innovatively to secure regulatory approval for medical devices

  Sometimes the best way to secure regulatory approval requires the project manager to build a different box.

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  Top viewed StarFish Medical videos in 2015

  Top 10 2015 StarFish Medical videos help connect viewers with employees they may only know from reading or phone calls.

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  Our most read medical device blogs of 2015

  Top 2015 medical device blogs written by StarFish Medical expert employees sharing their knowledge, tips, and tools.

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