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  Why your medical device contract manufacturer will likely design your next product

  Why switch to a medical device specialist manufacturer? Hear from clients who moved to StarFish Medical from a non-medical contractor.

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  Sorting Through New and Final FDA Guidance Documents

  Highlights of July and August 2014 medical device FDA guidance documents that reduce regulatory burden without compromising patient safety.

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  Increasing IVD Regulatory Success

  Tips, considerations, and techniques to increase IVD Regulatory Success that is essential for many Medical Devices.

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  Will Consumer Electronics cause Medical Device Obsolescence?

  Will consumer electronics engulf the medical device development community, making rigorous testing and risk mitigation processes obsolete?

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  Faster Market Access for Less: Medical Device Single Audit Program (MDSAP)

  MDSAP enables Medical Device companies to save in Registrar’s fees, eliminate duplication of inspections and gain faster access to markets.

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  Describing StarFish: Client satisfaction

  Results of StarFish client satisfaction survey with a large group that included customers and prospects using one word descriptions.

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  How to write a Medical Device Quality Manual (3 simple rules)

  Regulatory affairs expert explains how to write a best practice ISO 9000 Medical Device Quality Manual using 3 simple rules.

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  Electro-Medical Device Basic Safety Learning Lab Highlights

  Highlights from Day 1 of Learning Lab event at Boston BIOMEDevice on electro-medical device basic safety and achieving compliance with 60601.

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  5 Top Annual Plan Medical Device Design and Development Process Improvement Recommendations

  Medical Device Design and Development Process Improvement for Annual Plan: limit improvement efforts, measure them regularly, succeed.

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