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  The Bleeding Edge and 510(k) approvals

  The Bleeding Edge explains how 510K cleared medical devices are clinically proven to improve patient outcomes and save lives.

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  10 things I learned from Bad Blood

  The book Bad Blood eloquently demonstrates the importance of properly developing medical devices under ISO 13485.

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  6 benefits of FDA Breakthrough Devices program

  6 benefits mean the FDA program for breakthrough medical devices may be your best regulatory option for novel medical devices.

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  Is the FDA Early Feasibility Studies Program right for you?

  FDA’s Early Feasibility Studies Program (EFS) is a great option in early stage development looking to advance your program by gathering data.

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  Navigating Medical Device International Regulations

  Proper research and communication with authorities in each country of interest will make Medical Device International Regulations smoother to navigate.

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  Preparing for ISO/IEC 17025:2017

  ISO/IEC 17025:2017 includes many changes. Three points to keep in mind: more options, involvement of risk, updates in current technology.

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  Are you getting the most of your decision matrix?

  Kepner-Tregoe’s original Decision Matrix overview with tweaks to make it broader and more robust.

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  3D Printed Medical Devices – Insight into the FDA Guidance on Additive Manufacturing

  FDA Guidance on Additive Manufacturing (AM) – offers new ways to integrate parts not only for prototypes, but for final products.

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  Avoid these 11 costly medical device development mistakes

  11 medical device development mistakes that surfaced frequently in a variety of products.  Avoid them to reduce cost and time to market.

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