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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 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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  7 Tips for Efficient Medical Device Submissions to IEC 60601 Edition 3

  Seven tips for a smooth and successful outcome.to IEC 60601 Edition 3 submissions and electrical safety testing

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  Benefits of Positive On-Site Inspection for Medical Device Development Companies

  Preparation for our medical device development and contract manufacturer On-Site inspection helped our client earn a successful Factory Inspection.

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  Errata – or – That’s Just Plain Codswallop!

  When designing medical devices, use trustworthy data sources! Reading the manufacturer’s spec sheets and errata is not sufficient for problem-free design.

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  FDA Recognized Standards List Number 30 for Medical Devices

  Updated FDA Recognized Standards for use in premarket reviews of medical devices with declaration of conformity to consensus standards.

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  Medical Device Internal Auditing – Making Friends with “Bad News”

  Medical Device Internal Auditing is vital in device development, but the results of an internal audit are not always easy to hear.

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  Extreme Risk Management in Medical Device Development

  Enjoy a smooth product development ride by apply an extreme risk management approach for device, manufacturing and project.

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  Proposed EU Medical Device Regulations (2012)

  Proposed EU Medical Device Regulations (2012) replace current Directives with two Regulations; one for medical devices and the other for IVDD

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