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Medtech Tips: How To Design With Safety In Mind

Guest author Paul Kostek of software engineering services firm Base2 Solutions offers device-makers pointers on how to mitigate certain risks and make sure that safety is always a top concern when products are designed.

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The medical device industry faces a unique set of challenges when it comes to complying with federal regulations and safety. The tracing and tracking of specifications necessary to move a product through the US Food and Drug Administration screening process is unavoidably strict. Companies must be cognizant of these requirements in each stage of the design process if they hope to release a successful product without lengthy and/or costly revisions.

About The Author

Paul Kostek is an advisory systems engineer at software engineering services firm Base2 Solutions, working with companies in defining system architecture, system requirements and risk assessment.

For devices, risk management standard ISO 14971 from the International Organization for Standardization is used worldwide for designing with...

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