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Home » Store » Webinar Recordings » Device Design and Risk Management - Webinar CD/Transcript

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Audio CD/Transcript - June 22, 2017

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Device Design and Risk Management - Webinar CD/Transcript

$287.00
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Product Details

Device Design and Risk Management

Medical device design is linked inextricably with risk management. Risk reduction measures become design inputs. Implementation verification, a risk management activity, can work as design verification too.

Governing it all is an alphabet-soup of Quality Management Systems (QMS) provisions including ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, and EN ISO 13485:2016, as well as risk management requirements in the common Risk Management Systems (RMS): ISO 14971:2007 and EN ISO 14971:2012.

Order this session with a leading authority on in quality, operations, and program management in medical device design and manufacture.

Dan O’Leary of Ombu Enterprises has a long track record training operations management professionals via a unique systems approach perfected over 30 years of training. In 90 fast-paced minutes, he’ll cover a lot of ground:

  • Overview: Design control from the risk management perspective
  • Overview: Risk management from the design control perspective
  • When, where and how the two system interact
  • Recognizing when requirements of the one system support/complement requirements of the other
  • Using product safety standards to improve design control and risk management efficiency
  • And much more! 

Bonus! A chart showing relationships between the clauses of EN ISO 13485:2012 and EN ISO 14971:2012.

Better design and smoother operations benefit everyone — your employer, your customers, maybe your paycheck too. It’s well worth 90 minutes out of your week to sharpen skills and increase professional standing. Order now.

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