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  Medical Device Development is Child’s Play

  Some clients mostly just want the job done; others are keen to be embedded in the medical device development process. I like both.

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  3 Golden Rules for Managing Subcontractors

  Tips for managing subcontractors —especially in regulatory submissions, EMC testing, injection moulding, and rapid prototyping.

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  Medical Device Design Documentation Risk Management, Verification & Validation (V&V), and Standards Tips

  Risk Management, Verification & Validation (V&V), and Standards tips for Medical Device Design Documentation. FDA 21 CFR 820 QSR regulations.

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  Planning, Input and Architecture Tips for Medical Device Design Documentation

  Three medical device design documentation tips for Planning, Input and Architecture when developing early stage medical devices.

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  Drawing Ponies and IEC 62366

  Using a design approach to investigate the user’s needs provides a head start on ISO 60601 Ed. 3 and IEC 62366 medical devices

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  A touchy subject: The (mis)use of touchscreens in medical device development

  Less is always more in medical device development. The (mis)use of touchscreens in medical device development.

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  Inexpensive prescreening strategies for medical device EMC compliance

  Inexpensive to build equipment with strategies and tips for successful medical device EMC compliance prescreening.

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  6 Areas to Watch in FDA Wireless Guideline for Medical Device Development

  FDA Wireless Guideline is a guidance document for RF wireless technology in medical devices recommending a risk-based approach.

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  ISO 21500 and Medical Device Development

  ISO 21500 and PMI provide guidance for Medical Device Development and Project Management Officer at StarFish Medical.

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