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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

• 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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  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.

• ISO 21500 and Medical Device Development

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

• ISO 10993-1 FDA Change Could Significantly Impact your Biocompatibility Plans

  ISO 10993-1 and Biocompatibility impact on Medical Device Plans. Financial impact of additional Medical Device testing will have a cost.

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  Polarity Thinking in Medical Device Development

  Polarity mapping is a valuable element of medical device development for efficiency, quality, change, stability, debate, unity, progress and reflection.

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