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  Optimizing Medical Device Design Value AND Innovation

  Ideas and examples of turning innovation vs. value into innovation AND value while optimizing medical device design.

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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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  5 Things You Should Know About Making a Medical Device Manufacturable

  Making a medical device manufacturable is a common scope of work. 5 ‘make it manufacturable’ suggestions for 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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  5 Tips for FDA 510(k) Medical Device Regulatory Clearance

  FDA 510(k) medical device submission tips and advice: being adequately prepared is essential for a smooth submission.

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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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