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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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  Safety and business implications for lithium batteries in medical devices

  Safety implications to choosing lithium batteries in medical devices as well as practical business implications. Avoid these pitfalls.

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  Think ABCD for medtech project management of innovation

  To adapt project management of innovation for medtech product development, use Attitude, Building (and testing), Communication and Definition.

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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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  Truly great project managers find ways to say “Yes”

  Good medical device project managers say “No” and they say it often. Truly great project managers find ways to say “Yes”.

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